MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES

K961632 · Johnson & Johnson Medical, Inc. · KGO · Jul 3, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961632
• Device Name: MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

MICRO-TOUCH* Powder Free Latex Surgical Gloves are intended for single use in a variety of hospital and surgical procedures to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.

Device Story

Sterile, single-use, powder-free latex surgical gloves; Type 1 rubber latex per ASTM D 3577-91; white color; sizes 5-1/2 through 9. Used by clinicians in hospital/surgical environments to provide barrier protection against blood, body fluids, and cross-contamination of sterile fields. Manufacturing process modified from predicate to remove powder; final product verified negative for starch via USP iodine test.

Clinical Evidence

No clinical tests conducted. Nonclinical evidence includes ASTM D-3577-91 compliance, 21 CFR 800.20 testing, rabbit primary skin irritation, guinea pig delayed contact sensitization, and USP iodine starch testing.

Technological Characteristics

Type 1 rubber latex; ASTM D 3577-91 compliant; non-powdered; sterile; sizes 5-1/2 to 9.

Indications for Use

Indicated for use by healthcare personnel in hospital and surgical settings to provide a barrier against body fluids, blood, and microbiological contamination during procedures.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• MICRO-TOUCH Latex Surgical Gloves

Submission Summary (Full Text)

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K961632
JUL - 3 1996

# 510(k) Summary

## MICRO-TOUCH* POWDER FREE LATEX SURGICAL GLOVES

Page 1 of 2

| Submitter's Name: | Johnson & Johnson Medical Inc. |
| --- | --- |
| Submitter's Address: | 2500 Arbrook Blvd
Arlington, Texas 76014 |
| Submitter's Phone Number: | [phone] |
| Submitter's Fax Number: | [phone] |
| Name of Contact Person: | Margaret Marsh |
| Date of Preparation: | April 26, 1996 |
| Name of Device:
Trade Name:
Common Name:
Classification Name: | MICRO-TOUCH* Powder Free Latex Surgical Gloves
Surgical Gloves
Surgeon's Gloves |
| Legally Marketed Device to Which Equivalency is Being Claimed: | MICRO-TOUCH Powder Free Latex Surgical Gloves as described in this 510(k) notification are substantially equivalent to the currently marketed MICRO-TOUCH Latex Surgical Gloves. The manufacturing differences between the two products consist of additional steps needed to render the gloves powder free. |
| Description of the Device: | MICRO-TOUCH Powder Free Latex Surgical Gloves meet the description of Rubber Surgical Gloves as described in American Society for Testing Materials (ASTM D 3577-91) as Type 1 gloves compounded primarily from rubber latex. They are white in color and are non-powdered. They are packaged sterile in pairs in sizes 5-1/2 through 9. |

* Trademark

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K961632

# 510(k) Summary

# MICRO-TOUCH* POWDER FREE LATEX SURGICAL GLOVES

Page 2 of 2

| Intended Use of the Device: | MICRO-TOUCH* Powder Free Latex Surgical Gloves are intended for single use in a variety of hospital and surgical procedures to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer. |
| --- | --- |
| Summary of Technological Characteristics Compared to the Predicate Device: | The current notification describes minor modifications to the manufacturing process which allow for a powder free product. |
| Brief Discussion of Nonclinical Tests: | Testing performed per ASTM D-3577-91 and 21 CFR 800.20 indicates that the product meets the requirements of these standards.
Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization.
Final product is negative for the presence of starch using the USP iodine test. |
| Brief Discussion of Clinical Tests: | No new clinical tests were conducted under this 510(k). |
| Conclusions Drawn for the Nonclinical and Clinical Tests: | Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatibility requirements. |
| Other Information Deemed Necessary by FDA: | Not applicable |

* Trademark