PROTEC STERILE GAUZE SPONGE
Device Facts
| Record ID | K961773 |
|---|---|
| Device Name | PROTEC STERILE GAUZE SPONGE |
| Applicant | Derivadas Degasa S.A. DE C.V. |
| Product Code | EFQ · SU |
| Decision Date | Jul 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Therapeutic |
Indications for Use
DeGasa Sterile USP Gauze Sponges are used in a hospital setting where sterile gauze is required. The instructions for use by physicians using gauze sponges are exactly the same as the instructions for use found on present labeling for similar products currently on the market.
Device Story
Protec Sterile Gauze Sponge; 100% cotton plain woven cloth; USP type VII specification. Used in hospital settings by physicians/clinical staff for wound management/surgical procedures. Device provides sterile absorbent barrier. No complex processing or electronic components.
Clinical Evidence
Bench testing only; physical property comparison to predicate device.
Technological Characteristics
100% cotton; plain woven cloth; USP type VII specification; sterile.
Indications for Use
Indicated for use in hospital settings requiring sterile gauze for general wound care and surgical applications.
Predicate Devices
- Keilei International (K895086)
Related Devices
- K962972 — SURGICADE GAUZE SPONGE · Accunex Canada,Inc. · Oct 11, 1996
- K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE · Furlong Industries · Aug 12, 1999
- K971075 — PRIMED PRIME-PLUS COTTON GAUZE SPONGES · Primeline Medical Products, Inc. · Jun 22, 1997
- K983450 — STARRYSHINE GAUZE SPONGE · T.C. Dental Products, Inc. · Nov 12, 1998
- K983016 — GAUZE, SPONGES, CAT # 11-003 · Vitalcare Group, Inc. · Feb 12, 1999
