Identity
- Trade Name
- Criterion FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Criterion Surgical Glove Latex Size 6.0 FDA UDI
- Model / Reference
- 5704496 FDA UDI
- Description
- Criterion Surgical Glove Latex Size 6.0 FDA UDI
Identifiers
- Catalog Number
- 5704496 FDA UDI
- Primary DI / UDI-DI
- 10304040190118 FDA UDI
- 510(k) Number
- K190241 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Hevea-latex surgical glove, non-powdered, non-antimicrobial
Criterion by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hevea-latex surgical glove, non-powdered, non-antimicrobial.
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Cleared under the same submission
K190241 also covers:
- ORCARE SURGICAL LATEX PF — CAREGLOVE GLOBAL SDN. BHD.
- ORCARE SURGICAL LATEX PF — CAREGLOVE GLOBAL SDN. BHD.
- ORCARE SURGICAL LATEX PF — CAREGLOVE GLOBAL SDN. BHD.
- ORCARE SURGICAL LATEX PF — CAREGLOVE GLOBAL SDN. BHD.
- ORCARE SURGICAL LATEX PF — CAREGLOVE GLOBAL SDN. BHD.
- ORCARE SURGICAL LATEX PF — CAREGLOVE GLOBAL SDN. BHD.
- ORCARE SURGICAL LATEX PF — CAREGLOVE GLOBAL SDN. BHD.
- ORCARE SURGICAL LATEX PF — CAREGLOVE GLOBAL SDN. BHD.
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (1)
- FDA UDI b75f1a30-df2e-4f7c-a3eb-80458604ffe1 35 fields · synced May 30, 2026