← Product Code [LZA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA) · K965095 # NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K965095) _Ansell Edmont Industrial, Inc. · LZA · Apr 22, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K965095 ## Device Facts - **Applicant:** Ansell Edmont Industrial, Inc. - **Product Code:** [LZA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA.md) - **Decision Date:** Apr 22, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner. ## Device Story Nitra-Touch™ is a disposable nitrile examination glove; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Device provides barrier protection; features high puncture resistance (8x greater than vinyl, 2x greater than competitive nitrile) and chemical resistance to glutaraldehyde. Used in clinical settings; operated by healthcare professionals. Output is physical barrier protection; affects clinical decision-making by ensuring sterile/clean environment during patient examinations. ## Clinical Evidence No clinical data. Bench testing only. Performance verified via ASTM D 3578 (dimensions, physical properties), ASTM D 5151 (freedom from holes), ASTM F739-91 (glutaraldehyde resistance), and biocompatibility studies (primary skin irritation in rabbits, guinea pig sensitization). ## Technological Characteristics Nitrile film material. Dimensions and physical properties meet ASTM D 3578 (except ultimate elongation: 500% original, 400% aged). Puncture resistance 1625 lbf/in (ASTM D 120-87). Tensile strength 17.1 MPa. Powder-free (<2 mg residue). Biocompatible. ## 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. ## 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} Ansell Edmont Industrial Ansell Edmont Industrial Inc. 400 Northridge Rd. Suite 800 Atlanta, Georgia 30350 Telephone: (770) 641-1900 FAX: (770) 641-1988 K965055 Nitra-Touch™ Checklist Section 21.0 [1] 510 (k) Summary [2] Ansell Edmont Industrial, Inc. 400 Northridge Road, Suite 800 Atlanta, GA 30350 APR 22 1997 Telephone: 770-641-1900 Fax: 770-641-1988 Contact: Mike W. Hagans Telephone: 614-623-3595 Fax: 614-623-3515 December 12, 1996 [3] Trade Name: Nitra-Touch™ Common Name: Exam Gloves Classification Name: Patient Examination Glove [4] Nitra-Touch™ examination gloves, meet all of the requirements of ASTM D 3578 with the following variation. [5] Nitra-Touch™ examination gloves meet all the current specifications for ASTM D 3578 Rubber Examination Gloves except for the ultimate elongation percentage before and after aging. [6] Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner. [7] Nitra-Touch™ examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards. | Characteristics | Standard | | --- | --- | | Dimensions | Meets ASTM D 3578 | | Physical Properties | Meets ASTM D 3578 | | Except Ultimate Elongation meets specifications described under Attachment II | Original Ultimate Elongation 500% minimum Aged Ultimate Elongation 400% minimum | Revised 2/21/97 {1} Ansell Edmont Industrial Ansell Edmont Industrial Inc. 400 Northridge Rd. Suite 800 Atlanta, Georgia 30350 Telephone: (770) 641-1900 FAX: (770) 641-1988 Nitra-Touch™ Freedom from holes Meets ASTM D 3578 Meets ASTM D 5151 Powder-Free Meets described test in Attachment V Not more than 2 mg residue by mass. Tensile Strength 60% higher than vinyl (synthetic) examination gloves Puncture resistance of Nitra-Touch™ is eight (8) times greater than vinyl and nearly twice that of competitive nitrile gloves Nitrile film provides excellent chemical resistance to glutaraldehyde. Tensile Strength MPa ASTM D 5250 ASTM D 3578 Vinyl = 10.5 Nitra-Touch™ = 17.1 Puncture lbf/in ASTM D 120-87 Nitra-Touch™ = 1625 Blue Nitrile = 929 Vinyl (Synthetic) = 184 Glutaraldehyde Resistance ASTM T F739-91 Source: TRI/Environmental, Inc. Breakthrough Time = >480 Permeation Rate = <0.013 µg/cm²* min Biocompatibility Primary Skin Irritation in Rabbits Guinea Pig Sensitization Passes Passes [8] The performance test data of the non clinical tests are the same as mentioned immediately above. [9] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. [10] It is concluded that Nitra-Touch™ examination gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product. [11] This summary will include any other information reasonably deemed necessary by The FDA. Revised 2/21/97 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K965095](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K965095) **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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