Identity
- Trade Name
- KIMTECH PFE LATEX EXAM GLOVES (L) FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Examination Gloves FDA UDI
- Model / Reference
- 57440 FDA UDI
- Description
- Examination Gloves FDA UDI
Identifiers
- Catalog Number
- 57440-53 FDA UDI
- Primary DI / UDI-DI
- 00036000574401 FDA UDI
- 510(k) Number
- K990539 FDA UDI
- FDA Product Code
- LYY FDA UDI
- GMDN Term
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Kimtech Pfe Latex Exam Gloves (l) by Kimberly-Clark Global Sales, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K990539 also covers:
- KIMTECH COMFORT LATEX POWDER-FREE EXAM GLOVES (L) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH COMFORT LATEX POWDER-FREE EXAM GLOVES (M) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH COMFORT LATEX POWDER-FREE EXAM GLOVES (S) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH COMFORT LATEX POWDER-FREE EXAM GLOVES (XL) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH COMFORT LATEX POWDER-FREE EXAM GLOVES (XS) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH COMFORT LATEX POWDER-FREE EXAM GLOVES (XXL) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PFE LATEX EXAM GLOVES (M) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PFE LATEX EXAM GLOVES (S) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PFE LATEX EXAM GLOVES (XL) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PFE LATEX EXAM GLOVES (XS) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PFE-XTRA LATEX EXAM GLOVES (L) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PFE-XTRA LATEX EXAM GLOVES (M) — KIMBERLY-CLARK GLOBAL SALES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kimberly-Clark Global Sales, Inc.
Sources (1)
- FDA UDI 3f1bd252-54e4-4202-8836-2ba86b75bd74 37 fields · synced May 30, 2026