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Kimtech Purple Nitrile Exam Gloves, Sterile Pairs (s)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE PAIRS (S) FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Examination Gloves FDA UDI
- Model / Reference
- 55091 FDA UDI
- Description
- Examination Gloves FDA UDI
Identifiers
- Catalog Number
- 55091-54 FDA UDI
- Primary DI / UDI-DI
- 10036000550914 FDA UDI
- 510(k) Number
- K102032 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
Yes
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
Radiation Sterilization FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Kimtech Purple Nitrile Exam Gloves, Sterile Pairs (s) by Kimberly-Clark Global Sales, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
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- 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
K102032 also covers:
- KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE PAIRS (L) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE PAIRS (M) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE SINGLES (M) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE SINGLES (S) — KIMBERLY-CLARK GLOBAL SALES, INC.
- KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE SINGLES (XS) — KIMBERLY-CLARK GLOBAL SALES, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, INC.
- Halyard — O&M HALYARD, 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
- Kimberly-Clark Global Sales, Inc.
Sources (1)
- FDA UDI 3364fdd0-687f-4e26-9417-d8ad19e2bbf4 37 fields · synced May 30, 2026