← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K962188 # COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) (K962188) _Wembley Rubber Products (M) Sdn Bhd · LYY · Jul 26, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K962188 ## Device Facts - **Applicant:** Wembley Rubber Products (M) Sdn Bhd - **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md) - **Decision Date:** Jul 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient’s body, fluids, waste, or environment. ## Device Story Device is a powder-free, low-protein, hypoallergenic latex patient examination glove. Used by healthcare and operating room personnel as a protective barrier to prevent contamination between the wearer and the patient's body, fluids, waste, or environment. Device functions as a physical barrier; no electronic or mechanical components. ## Clinical Evidence Clinical study conducted on 200 human subjects using the Modified Draize test. Results demonstrated no potential for eliciting dermal irritation or sensitization, supporting the 'hypoallergenic' labeling claim. ## Technological Characteristics Latex patient examination glove; powder-free; low protein (<50 µg/g). Meets ASTM D3578-91 standards for dimensions, tensile strength, and ultimate elongation. Watertight integrity verified via 1000 ml test (AQL 2.5). ## 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} WKP CONTACT PERSON : MR. Y.W. CHOW WEMBLEY RUBBER PRODUCTS (M) SDN BHD Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor, Malaysia. Corporate Office Tel: 8461486 8461867 Fax: 8461485 8461557 Factory Office: 8461495 8461496 Fax: 8461488 8461608 K962188 JUL 26 1996 # 510 (K) SUMMARY 1. **Trade Name** : COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) 2. **Common Name** : Examination Gloves 3. **Classification Name** : Patient Examination Glove 4. **Substantial Equivalence** : Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, that meets all of the requirements of ASTM standard D3578-91. 5. **Description of device** : Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, that meets all of the requirements of ASTM standard D3578-91. 6. **Intended use of device** : The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient’s body, fluids, waste, or environment. Page 1 of 3 BS EN ISO 9002 : 1994 BRITISH STANDARDS INSTITUTION REGISTRATION NO: FM 13934 GOOD MANUFACTURING PRACTICE UK DEPARTMENT OF HEALTH REGISTRATION NO: R0589/SP REGISTERED MALAYSIA QUALITY SYSTEM MS ISO 9002 : 1991 REGISTRATION NO: AR 0027 {1} Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test. | TEST | ASTM D 3578-91 | COMFIT Powder Free Blue Examination Gloves (Hypoallergenic, Low Protein) | | --- | --- | --- | | 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 2.5 | | 2. Length (mm) | | | | Size | XS | - | | | S | min 230 | | | M | min 230 | | | L | min 230 | | | XL | - | | 3. Palm width (mm) | | | | Size | XS | - | | | S | 80 ± 10 | | | M | 95 ± 10 | | | L | 111 ± 10 | | | XL | - | | 4. Thickness (mm) | | | | Finger | min 0.08 | 0.40 | | Palm | min 0.08 | 0.30 | | 5. Physical Properties | | | | Before Ageing : | | | | Tensile Strength (MPa) | min 21 | 31.23 | | Ultimate Elongation (%) | min 700 | 895 | | After Ageing : | | | | Tensile Strength (MPa) | min 16 | 26.64 | | Ultimate Elongation (%) | min 500 | 946 | | 6. Powder Content | - | below 2 mg / glove | | 7. Protein Content | - | below 50 microgram / gram | Page 2 of 3 {2} Page 3 of 3 ## 8. Substantial Equivalence based on assessment of Non-Clinical performance data The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-91. Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram. ## 9. Assessment of Clinical Performance data Clinical data of 200 Human subjects on Modified Draize test done on this glove demonstrated no potential for eliciting either dermal irritation or sensitization and support the labeling claim for “hypoallergenic”. ## 10. Conclusion This glove exceeds the ASTM D 3578-91 requirements, meet pinhole FDA requirements, meet Hypoallergenic labeling claim and below 50 microgram / gram protein content labeling claim. Date Summary Prepared : May 27, 1996 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K962188](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K962188) **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