Identity
- Trade Name
- Schneider FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Schneider Disposable Powder-Free Nitrile Exam Gloves, 4 mil, Black, NBFK7113, 50ct Box, Size L FDA UDI
- Model / Reference
- NBFK7113 FDA UDI
- Description
- Schneider Disposable Powder-Free Nitrile Exam Gloves, 4 mil, Black, NBFK7113, 50ct Box, Size L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850028934531 FDA UDI
- 510(k) Number
- K133307 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile 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
Yes
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: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Schneider by Avatech Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133307 also covers:
- Truline — ARBILL INDUSTRIES, INC.
- Truline — ARBILL INDUSTRIES, INC.
- Truline — ARBILL INDUSTRIES, INC.
- Truline — ARBILL INDUSTRIES, INC.
- Truline — ARBILL INDUSTRIES, INC.
- Truline — ARBILL INDUSTRIES, INC.
- Akers — Akers Industries, Inc.
- Akers — Akers Industries, Inc.
- Schneider — Avatech Corp.
- Schneider — Avatech Corp.
- Schneider — Avatech Corp.
- Schneider — Avatech Corp.
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
- Avatech Corp.
Sources (1)
- FDA UDI 5ae75792-93e1-4c2b-b592-3818d8093aea 37 fields · synced May 30, 2026