Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- CRITERION PC GLOVE PF LTX SIZE S FDA UDI
- Model / Reference
- 5703413 FDA UDI
- Description
- CRITERION PC GLOVE PF LTX SIZE S FDA UDI
Identifiers
- Catalog Number
- 5703413 FDA UDI
- Primary DI / UDI-DI
- 10304040171759 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
Yes
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
Henry Schein by Henry Schein, Inc. — 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
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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 1e1659bc-e5b4-449b-a9b9-6cb0cbea29db 34 fields · synced May 31, 2026