Identity
- Trade Name
- PrimaPro FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- PrimaPro GentleGuard Latex Powder Free Examination Glove X-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use FDA UDI
- Model / Reference
- 314-45 FDA UDI
- Description
- PrimaPro GentleGuard Latex Powder Free Examination Glove X-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850022371332 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PrimaPro by Primary Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial.
- VGUARD — Vanguard International Solutions, LLC · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- MICROFLEX — Ansell Healthcare Product · Class I
- VIVIT Supply — Vivit Supply LLC · Class I
- Uniseal SureGrip — Uniseal · Class I
- Amtouch - Rely-a-Grip — AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. · Class I
- AmbiCanner — SUMMIT GLOVE INC. · Class I
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 (L) — 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.
K990541 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Primary Products Company
Sources (1)
- FDA UDI 380c3570-88e2-408f-a776-3db4ec6ca33b 34 fields · synced Jun 8, 2026