← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K964474 # ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES (K964474) _Allegiance Healthcare Corp. · KGO · Mar 11, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K964474 ## Device Facts - **Applicant:** Allegiance Healthcare Corp. - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** Mar 11, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Intended Use Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination. ## Device Story Sterile, powder-free surgical gloves; composed of natural rubber latex; intended for use by operating room personnel in hospitals/healthcare facilities; provides barrier protection for surgical wounds during invasive and non-invasive procedures; prevents contamination between patient and clinician. ## Clinical Evidence Bench testing only. Biocompatibility: primary skin irritation (negative), systemic toxicity (negative), intracutaneous reactivity (none), hemocompatibility (no lysis), guinea pig maximization (no irritation). Physical: tensile strength/elongation meet ASTM D3577-91; barrier defects meet 21 CFR §800.20 (AQL 2.5); powder-free status verified via vacuum filtration (<2 mg/glove) and negative iodine test. ## Technological Characteristics Material: natural rubber latex. Form factor: surgical glove. Performance standards: ASTM D3577-91 (tensile strength/elongation), 21 CFR §800.20 (barrier integrity). Designation: powder-free (vacuum filtration/iodine test). Sterilization: sterile. ## 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 - Triflex® Sterile Latex Powder-Free Surgical Gloves ## 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} MAR 11 1997 K964474 # XIV. SUMMARY OF SAFETY AND EFFECTIVENESS ## Allegiance ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ### ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES **Manufacturer:** Allegiance Healthcare Sdn. Bhd. Plot 87 Kampung Jawa 11900 Bayan Lepas Penang, West Malaysia **Regulatory Affairs Contact:** Maryalice Smith Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, IL 60085 **Telephone:** (847) 785-3322 **Date Summary Prepared:** February, 1997 **Product Trade Name:** Ultrafree Sterile Latex Powder-Free Surgical Gloves **Common Name:** Surgical Glove **Classification:** Glove, Surgical **Predicate Devices:** Triflex® Sterile Latex Powder-Free Surgical Gloves **Description:** The Ultrafree Surgical gloves are formulated using natural rubber latex and offered sterile. **Intended Use:** Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination. 18 {1} Page 2 ## Substantial Equivalence: The Ultrafree Sterile Latex Powder-Free Surgical Gloves are substantially equivalent to Triflex® Sterile Latex Powder-Free Surgical Gloves in that they provide the following characteristics: - intended use - size, configuration, packaging - made of natural rubber latex - tensile strength and thickness profiles ## Summary of Testing: | Test | Result | | --- | --- | | Primary Skin Irritation | Glove does not display any potential for irritation. | | Systemic Toxicity | Glove does not elicit any toxic reactions to acute application. | | Intracutaneous Reactivity | No reactivity was observed. | | Hemocompatibility | Gloves are hemocompatible exhibiting no lysis. | | Guinea Pig Maximization | Glove does not display any potential for irritation. | | Ultimate Elongation & Tensile Strength | Glove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91. | | Barrier Defects | Glove meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5. | | Data/Test Method | Glove meets powder level requirements for “Powder Free” designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2 mg/glove cornstarch level including negative iodine test. | --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K964474](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K964474) **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