Identity
- Trade Name
- BYTECH FDA UDI
- Generic Name
- Vinyl examination/treatment glove, non-powdered FDA UDI
- Model / Reference
- Powdered,L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974034761531 FDA UDI
- 510(k) Number
- K201504 FDA UDI
- FDA Product Code
- LYZ FDA UDI
- GMDN Term
- Vinyl examination/treatment glove, non-powdered 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: Vinyl examination/treatment glove, non-powdered
Bytech by Anhui Bytech Medical Supplies Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vinyl examination/treatment glove, non-powdered.
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- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Inspire — K2 HEALTH PRODUCTS · Class I
- SYNA MEDICAL — MEDLINE INDUSTRIES, INC. · Class I
- Life Guard — Lifeguard Inc. · Class I
- Durasafe — Durasafe Inc. · Class I
Cleared under the same submission
K201504 also covers:
- BYTECH — ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
- BYTECH — ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
- BYTECH — ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
- BYTECH — ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
- BYTECH — ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
- BYTECH — ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
- BYTECH — ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.
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
- Anhui Bytech Medical Supplies Co., Ltd.
Sources (1)
- FDA UDI 3d12675a-60f8-4ddc-9205-1f3eb25deaa1 33 fields · synced May 30, 2026