← Product Code [LZA](/productcode/LZA) · K955464 # TACTYLON POWDER FREE EXAMINATION GLOVE (K955464) _Tactyl Technologies, Inc. · LZA · Apr 25, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K955464 ## Device Facts - **Applicant:** Tactyl Technologies, Inc. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Apr 25, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. ## Device Story Synthetic, powder-free examination glove; mimics latex without natural rubber latex. Used in clinical settings by healthcare providers to prevent cross-contamination. Features added coating for donning without corn starch. Device is disposable. Provides barrier protection; reduces risk of powder-related irritation or contamination. ## Clinical Evidence Bench testing only. Biocompatibility: Delayed Contact Sensitization Study (Guinea Pig) showed no evidence of delayed dermal sensitization. Primary Skin Irritation Test (New Zealand white albino rabbit) showed no primary skin irritation. Water tightness testing performed per 21 CFR 800 (1000 ml water test) with AQL of 4.0. ## Technological Characteristics Material: TACTYLON™ (synthetic, latex-free). Powder-free with treated donning coating. Physical properties meet ASTM 3578-91. Water tightness tested per 21 CFR 800. ## Regulatory Identification A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. ## Predicate Devices - TACTYLON™ Examination Glove ([K905109](/device/K905109.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} TACTYL TECHNOLOGIES, INC. K955464 2595 COMMERCE WAY VISTA, CA 92083 TEL. (619) 598-2233 FAX (619) 598-1012 DUPLICATE # Powder Free Examination Glove 510(k) Summary ## A. SUBSTANTIAL EQUIVALENCE: Substantial equivalence is shown by comparing the subject device, a powder-free examination 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 APR 25 1996 Date Prepared: 12 April, 1996 2. Facility Registration: 2027921 Classification Name: 80LYY Common Name: Powder Free Examination Glove Proprietary Name: TACTYLON™ Powder Free Examination Glove 3. Substantially Equivalent Device: TACTYLON™ Examination Glove [510(k) K905109] 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 5. Device Class: I 6. Contact Person: Jorge Haider Director of Regulatory Affairs & Quality Assurance {1} # B. DEVICE DESCRIPTION: Tactyl's powder free examination 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 3578-91 Rubber Examination Gloves. The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. # C. COMPARISON TO TACTYLON™ EXAMINATION GLOVE: The powder free glove has dramatically reduced powder levels from its equivalent, TACTYLON™ examination 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 3578 and remain comparable to TACTYLON™ examination 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 4.0 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. ![img-0.jpeg](img-0.jpeg) --- **Source:** [https://fda-staging.innolitics.com/device/K955464](https://fda-staging.innolitics.com/device/K955464) **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. 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