PROTEC STERILE GAUZE SPONGE

K961773 · Derivadas Degasa S.A. DE C.V. · EFQ · Jul 29, 1996 · SU

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

Intended 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)

Submission Summary (Full Text)

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JUL 29 1996
K961773

# 510(K) SUMMARY
(as required by 807.92(c))

## Submitter of 510(k):
Regulatory & Marketing Services, Inc. (RMS)
40178 U.S. 19 North
Tarpon Springs, FL 34689

Phone: [phone]
Fax: [phone]

## Contact Person:
Patrick J. Lamb

## Date of Summary:
May 6, 1996

## Trade Name:
Protec Sterile Gauze Sponge

## Classification Name:
Gauze Sponge

## Predicate Device:
Keilei International K895086

## Device Description/
DeGasa USP Gauze are sterile gauze sponges that are made with 100 % cotton, and are in the form of plain woven cloth conforming to the specifications of USP type VII.

## Comparison:

| Protec | Keilei |
| --- | --- |
| Threads per 2.54 cm Warp | Same |
| Threads per 2.54 cm Filling | Same |
| Avg. count per 6.45 sq. cm | Same |
| Weight: g per sq. meter | Same |

## Intended 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.