ISO 13485
Quality management certificate covering Intercambio Global Latinoamérica, S.A. de C.V. scope and expiry. Upload certificate
Compliance Library
This library keeps every document buyers and regulators ask for straight from the source. We use FDA accurate language (registered/listed for establishments and devices; 510(k) cleared only where applicable) and never label PPE as FDA approved. Verify everything here and mirror the file names across WordPress, quotes, and shared folders.
Document control: Review cadence is quarterly. We refresh PDFs within 10 business days of any certificate renewal, scope change, or retest. FDA registration and listing data is updated weekly (typically Monday) in the public database, so minor timing differences may appear between internal files and FDA.gov.
Quality systems and certifications
Sterilization validation
Method (EO or Gamma), SAL 10^-6, lab, and issuance date for sterile products. Upload validation pack
FDA and SAM registrations
U.S. FDA establishment data plus SAM.gov proof for importer and distributor records. Upload documentation
Internal QA summary
Audit cadence, key controls, and responsible team. Upload overview
Download our documentation
Everything from FDA registration proof to packaging specs lives in our download hub. Share this link internally so everyone pulls from the same source of truth.
FDA / U.S. Compliance
- FDA Establishment Registration
- Device Listing certificates
- 510(k) summaries (if applicable)
- Letter of Authorization (LOA) for import
- ESG / FDA Importer ID (for transparency)
Quality & Manufacturing
- ISO 13485 certificate
- ISO 9001 certificate (if applicable)
- GMP compliance letter
- Sterilization validation reports (EtO / Steam)
- Biocompatibility testing
- Viral penetration testing (ASTM F1671)
- Synthetic blood penetration testing
- Flammability testing
- Cytotoxicity / irritation testing
- Shelf-life validation summary
- Environmental monitoring summary
Standards & Performance
- AAMI PB70 level certifications for gowns
- ASTM F2100 mask performance charts
- Filtration and breathability reports
- Material safety data sheets (MSDS)
- Latex-free declarations
- Country-of-origin certification
Product Documentation
Product Specification Sheets
- Dimensions, materials, compliance standards
- Sterility status, color, weight, thickness
- Reference photo
Pack Configuration Sheets
- Standard pack layouts
- Premium pack layouts
- Custom pack capabilities
Instructions for Use (IFU)
- Sterile product IFUs
- Patient-contact material IFUs
UDI / GTIN Information
- Labeling examples and barcode formatting
- GMDN codes (optional)
Safety & Handling
- Storage requirements and disposal instructions
- Latex/chemical avoidance notes
Logistics, Packaging & Supply Chain Docs
Packaging & Palletization Specs
- Case pack, dimensions, and weight
- Pallet pattern, height, and weight
- HTS code, country of origin, labeling format
Lead Times & MOQs
- Standard lead-time bands
- Surge capacity details
- Production scheduling window and MOQ per SKU
- Emergency replenishment pathways
Logistics Flow Diagram
- Manufacturing → QA → CEDIS → Border crossing → U.S. 3PL → Customer
Certificates of Conformance
- Sample CoC for hospital reference
Border / Customs Compliance
- USMCA eligibility statement
- Certificate of Origin
- Importer/Exporter ID numbers
Corporate & Legal
Corporate Overview
- EIN, CAGE code, DUNS number
- Business registration documents (optional)
Insurance Certificates
- General liability
- Product liability
- Workers comp
Ethical & Compliance Policies
- Code of Conduct
- Anti-bribery and corruption statement
- Supply chain transparency policy
- Environmental impact statement
Terms & Conditions
- Sales terms and warranty
- Returns/claims policy
Privacy & Cookie Policies
- Privacy policy
- Cookie policy
U.S. regulatory status
FDA establishment registration
Importer (U.S.) and manufacturer (Mexico) registration numbers go here with prefilled RL links. Add RL links
FDA device listings
List by product family with product codes and listing IDs. Add listing exports
510(k) summaries
Upload only if you have clearance; include K number or note Not applicable. Upload 510(k)
Importer of record statement
PDF outlining importer role, EIN, and compliance contacts. Upload statement
Standards and test reports
Pair every performance claim with a current lab report. Follow the naming convention below.
Gowns - AAMI PB70
- AAMI_PB70_Gown_Level1_IGL_2025-10_v1.0.pdf
- AAMI_PB70_Gown_Level2_IGL_2025-10_v1.0.pdf
- AAMI_PB70_Gown_Level3_IGL_2025-10_v1.0.pdf
- ASTM_F1671_Gown_Level4_IGL_2025-10_v1.0.pdf
Masks - ASTM F2100
- ASTM_F2100_Mask_Level1_IGL_2025-10_v1.0.pdf
- ASTM_F2100_Mask_Level2_IGL_2025-10_v1.0.pdf
- ASTM_F2100_Mask_Level3_IGL_2025-10_v1.0.pdf
Procedure packs
- BOM_Pack_Standard_IGL_2025-10_v1.0.pdf
- Sterility_Pack_Premium_IGL_2025-10_v1.0.pdf
Accessories and other standards
Add ASTM or ANSI specs, slip resistance testing, or respirator reports as needed.
Doc naming format: <Standard>_<Product>_<Entity>_<YYYY-MM>_vX.Y.pdf
Labeling and IFUs
Keep bilingual assets and UDI data together so receiving teams can verify faster.
UDI and GTIN samples
Carton, inner pack, and sterile pack labels with GTIN, lot, expiry, and AAMI or ASTM level. Upload label pack
Instructions for use
Bilingual IFUs for gowns, masks, drapes, and accessory kits. Upload IFUs
UDI data table
Include SKU, device identifier, production identifier, performance level, and label version. Upload data sheet
Cross reference (Mexico to U.S.)
Map Mexican Clave Sector Salud codes to Florence SKUs and GTINs.
| Clave Sector Salud | Florence SKU | GTIN | Description | Sterility | AAMI or ASTM level |
|---|---|---|---|---|---|
| [Clave code] | [SKU] | [GTIN] | [Description] | [Sterile or Non sterile] | [Performance level] |
Downloadable master: Crosswalk_ClaveSectorSalud_to_US_SKU_2025-10_v1.0.csv
How to verify our regulatory status
1) Check FDA establishment registration
Use prefilled FDA Registration and Listing (RL) links for both entities. Replace the placeholders with your registration or FEI numbers.
U.S. Initial Importer (Florence Medical International)
FDA RL (prefilled):
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?RegistrationNumber=[INSERT_US_FEI_OR_REG]&start_search=1
Manufacturer (Intercambio Global Latinoamérica S.A. de C.V.)
FDA RL (prefilled):
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?RegistrationNumber=[INSERT_MX_FEI_OR_REG]&start_search=1
Confirm on the RL results page:
- Establishment name matches yours or the manufacturer
- Establishment type shows values such as Initial Distributor/Importer or Manufacturer
- Status displays Active with the current registration year
FDA states that registration or listing does not equal FDA approval; the RL database is a directory refreshed weekly (typically Monday). Reference: FDA Establishment Registration & Listing.
2) Confirm device listings by product code
Publish the RL detail links for each product family and walk buyers through the fields they should see.
| Device | Product code | Class | 21 CFR | RL detail link |
|---|---|---|---|---|
| Surgical masks | FXX | II | 878.4040 | .../rl.cfm?lid=[LID_FXX]&lpcd=FXX |
| Surgical gowns | FYA | II | 878.4040 | .../rl.cfm?lid=[LID_FYA]&lpcd=FYA |
| Surgical isolation gowns | FYC | II | 878.4040 | .../rl.cfm?lid=[LID_FYC]&lpcd=FYC |
| Non-surgical isolation gowns | OEA | I | 878.4040 | .../rl.cfm?lid=[LID_OEA]&lpcd=OEA |
- Open the RL detail link.
- Confirm Registered Establishment Name, Product Code, Device Class, and Regulation (878.4040).
- If a 510(k) is listed, cross-check it in the 510(k) database as needed.
Surgical gowns and surgical isolation gowns are Class II and typically require 510(k) clearance; non-surgical isolation gowns are Class I (exempt). Reference: FDA medical gown guidance.
3) Match test reports to your claims
Display this reminder near every download link so reviewers know exactly what each document covers.
- Gowns: List the AAMI PB70 level per SKU. Levels 1-3 rely on AATCC 42/127. Level 4 requires ASTM F1671 viral penetration testing.
- Masks: Quote the ASTM F2100 level and ensure the report includes BFE, PFE at 0.1 micron, delta P, synthetic blood, and flammability.
Document titles should name the standard, the device or model, the test lab, and the test date. That date must precede the first sale or marketing claim for the product.
Reference: CDC PPE standards guidance and ASTM F2100 classification details.
4) Reinforce your update cadence
Restate the process so procurement teams know the library is maintained.
- Review the library quarterly.
- Replace PDFs within 10 business days of a renewal, retest, or scope change.
- Note that FDA RL data is refreshed weekly; timestamp your exports if they differ from the live site.
FDA posts RL database refresh details at the top of each search page. Reference: FDA Establishment Registration & Listing.
Directions for buyers
- Need a document not listed? Email compliance@florenceinternational.health.
- Use this library in quotes, bids, and onboarding packets; do not create duplicate copies.
- CTAs: Download compliance docs - Request samples
Footer notes
- Registration or listing is not FDA approval. FDA approval applies to specific PMA devices; for PPE we use FDA accurate terms such as registered/listed or 510(k) cleared when applicable. Reference: FDA Establishment Registration & Device Listing.
- Only AAMI Level 4 gowns include ASTM F1671 viral penetration testing. Levels 1-3 are not viral-impermeable. Reference: CDC PPE standards.
Regulatory reminder: Registration/listing does not equal FDA approval. Use accurate language: registered/listed and 510(k) cleared when applicable. Reference: FDA Establishment Registration & Device Listing.