Identity
- Trade Name
- SKYN FDA UDI
- Generic Name
- Basic male condom, synthetic polymer FDA UDI
- Device Name
- SKYN Elite Large Non-Latex Condom, 3ct FDA UDI
- Model / Reference
- 210124 FDA UDI
- Description
- SKYN Elite Large Non-Latex Condom, 3ct FDA UDI
Identifiers
- Catalog Number
- 90202 FDA UDI
- Primary DI / UDI-DI
- 00792554902021 FDA UDI
- 510(k) Number
- K171172 FDA UDI
- FDA Product Code
- HIS FDA UDI
- GMDN Term
- Basic male condom, synthetic polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic male condom, synthetic polymer
Skyn by Lil Drug Store Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic male condom, synthetic polymer.
- SKYN — SURETEX LIMITED - BRANCH · Class II
- SKYN — SURETEX LIMITED - BRANCH · Class II
- SKYN — SURETEX LIMITED - BRANCH · Class II
- SKYN — SURETEX LIMITED - BRANCH · Class II
- SKYN — SURETEX LIMITED - BRANCH · Class II
- SKYN — SURETEX LIMITED - BRANCH · Class II
- SKYN — SURETEX LIMITED - BRANCH · Class II
- SKYN — SURETEX LIMITED - BRANCH · Class II
Cleared under the same submission
K171172 also covers:
- SKYN — LIL DRUG STORE PRODUCTS, INC.
- LIFESTYLES — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
- SKYN — SURETEX LIMITED - BRANCH
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 II | Pending data |
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Manufacturer
- Manufacturer
- Lil Drug Store Products, Inc.
Sources (1)
- FDA UDI 57b0a5ce-da5b-44bd-bb3c-22ff38a26a05 35 fields · synced Jun 8, 2026