← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K955419 # POWDER FREE TACTYLON SURGEONS GLOVE (K955419) _Tactyl Technologies, Inc. · KGO · Apr 15, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K955419 ## Device Facts - **Applicant:** Tactyl Technologies, Inc. - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** Apr 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## 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. ## Regulatory 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](/device/K902831.md)) - TACTYLON™ Powder Free Surgical Glove ([K950185](/device/K950185.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. (619) 598-2233 FAX (619) 598-1012 # 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 ii --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K955419](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K955419) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com