POWDER FREE TACTYLON SURGEONS GLOVE

K955419 · Tactyl Technologies, Inc. · KGO · Apr 15, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955419
• Device Name: POWDER FREE TACTYLON SURGEONS GLOVE
• Applicant: Tactyl Technologies, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Apr 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Indications for Use

The surgical glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Synthetic, powder-free surgical glove made of TACTYLON™ material; designed to mimic latex without natural rubber latex proteins. Used by operating room personnel to provide a sterile barrier, protecting surgical wounds from contamination. Features a specialized coating to facilitate donning without corn starch. Device provides physical protection during surgical procedures; benefits users by eliminating potential for latex-related allergic reactions and reducing powder-related complications.

Clinical Evidence

Bench testing only. Device passed FDA water tightness testing (21 CFR 800) with an AQL of 2.5%. Biocompatibility testing included a Delayed Contact Sensitization Study in guinea pigs (no evidence of sensitization) and a Primary Skin Irritation Test in New Zealand white albino rabbits (not a primary skin irritant).

Technological Characteristics

Synthetic rubber material (TACTYLON™). Meets ASTM 3577-91 Type II physical property requirements. Powder-free with specialized donning coating. Sterile. No electronic or software components.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. No specific patient population or contraindications described.

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

• TACTYLON™ Surgical Glove (K902831)
• TACTYLON™ Powder Free Surgical Glove (K950185)

Submission Summary (Full Text)

{0}

APR-10-96 WED 7:20 AM TACTYL TECHNOLOGIES
FAX NO. 6195981012
P. 6
K955419
TACTYL TECHNOLOGIES, INC.
K955419
APR 15 1996
2595 COMMERCE WAY
VISTA, CA 92083
TEL. [phone]
FAX [phone]

# Powder Free Sterile Surgical Glove 510(k) Summary

## A. SUBSTANTIAL EQUIVALENCE:

Substantial equivalence is shown by comparing the subject device, a powder-free surgical glove, to a previously marketed device with 510(k) clearance. The following information is submitted in compliance of a 510(k) summary as required by 21 CFR 807.92

1. Submitted by: Tactyl Technologies, Inc.
(& Manufactured by) 2595 Commerce Way
Vista, CA 92083
Date Prepared: 8 April, 1996

2. Facility Registration 2027921
Classification Name: 79KGO
Common Name: Powder Free Surgical Glove
Proprietary Name: TACTYLON™ Powder Free Surgeons Glove

3. Substantially Equivalent
Device: TACTYLON™ Surgical Glove [510(k) K902831]
TACTYLON™ Powder Free Surgical Glove
[510(k) K950185]

4. Marketed by: Tactyl Technologies, Inc.
2595 Commerce Way
Vista, CA 92083

Other firms may market the product under a private label agreement and sell under their own brand, one such firm is:

SmartCare
3400 East McDowell
Phoenix, AZ 85008-7899

{1}

APR-10-96 WED 7:20 AM TACTYL TECHNOLOGIES
FAX NO. 1.5000.00
P. 7

## B. DEVICE DESCRIPTION:

Tactyl’s powder free surgical gloves are manufactured using TACTYLON™. TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3577-91 Rubber Surgical Gloves, Type II, compounded from a rubber cement or from synthetic rubber latex. The surgical glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.

## C. COMPARISON TO TACTYLON™ SURGICAL GLOVE:

The powder free glove has dramatically reduced powder levels from its equivalent, TACTYLON™ surgical glove. The powder free glove has an added coat of material that is treated to provide donning characteristics without having to use corn starch. The physical properties of the glove remain well within the requirements established by ASTM 3577 and remain comparable to TACTYLON™ surgical gloves.

The product is tested to and has passed the FDA test for water tightness using 1000 ml of water as called for in 21 CFR 800. This test requires gloves to be mounted on a test fixture and 1000 ml of water must be added. Leakage is defined as water escaping through the glove in any area of the glove, except the top 1½ inches that is attached to the mounting fixture. Any leakage occurring after two minutes is considered a failure. Gloves must pass an Acceptable Quality Level (AQL) of 2.5% as defined in 21 CFR 800.

## D. CLINICAL AND NON-CLINICAL TESTING AND THEIR CONCLUSIONS:

Various biocompatibility tests were successfully performed. Delayed Contact Sensitization Study (Repeated Patch Method) was performed in the Guinea Pig and showed no evidence of causing delayed dermal sensitization in the guinea pig. Another test conducted was the Primary Skin Irritation Test (FHSA) in the New Zealand white albino rabbit. The test demonstrated the glove not to be a primary skin irritant.

Jorge Haider 10 April 96
Date
Director of Regulatory Affairs and Quality Assurance

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