Qualtex Surgical Drape
by Deroyal Industries, Inc. 2 variants
510(k) K910495
Qualtex Surgical Drape is a medical device (FDA Class II; FDA product code KKX, Drape, Surgical, Antimicrobial) made by Deroyal Industries, Inc., cleared under FDA 510(k) K910495 on 19 Feb 1991, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910495 | Date19 Feb 1991 | StatusActive |
Official records
- FDA 510(k) database K910495
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KKX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KKX (Drape, Surgical, Antimicrobial).
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- SENGEWALD CATALOG NUMBER 55 66 01 by Sengewald/USA, Inc.
- LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING by Palex Medical, Inc.