Identity
- Trade Name
- KIMTECH BLUE NITRILE EXAM GLOVES (L) FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Examination Gloves FDA UDI
- Model / Reference
- 50580 FDA UDI
- Description
- Examination Gloves FDA UDI
Identifiers
- Catalog Number
- 50580-53 FDA UDI
- Primary DI / UDI-DI
- 00036000505801 FDA UDI
- 510(k) Number
- K163267 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
KIMTECH BLUE NITRILE EXAM GLOVES (L) are a high-quality, single-use examination gloves designed for healthcare professionals. These gloves are made of durable nitrile material and have a protective barrier against patient contamination. They are ideal for use in general hospitals and other medical facilities where staff need to handle patients with sensitive skin.
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
- VitalGard® Nitrile — Dash Medical Gloves, Inc. · Class I
- Hongray — Grand Work Plastic Products Co., Ltd. · Class I
- Get-A-Grip — SUMMIT GLOVE INC. · Class I
- MARK3 — CARGUS INTERNATIONAL, INC · Class I
- NitriSkin XP — Medgluv Inc. · Class I
- First Aid Only — Acme United Corporation · Class I
- FINISHMASTER — Bunzl USA Holdings LLC · Class I
- Medicom AssureTouch — AMD Medicom Inc · Class I
Cleared under the same submission
K163267 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Kimberly-Clark Global Sales, Inc.
Sources (1)
- FDA UDI a2810db5-89e6-4b1a-8e50-f0930a7a1d46 37 fields · synced Oct 6, 2026