← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K953213 # COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) (K953213) _Wembley Rubber Products (M) Sdn Bhd · LYY · Oct 11, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K953213 ## 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:** Oct 11, 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 Comfit Powder Free Latex Examination Gloves are disposable, beaded, hypoallergenic latex gloves. Used by healthcare and operating room personnel to provide a protective barrier against contamination. Device functions as a physical barrier between the wearer and the patient or environment. Performance verified through physical property testing and biocompatibility assessment. ## Clinical Evidence Clinical performance supported by a Modified Draize test conducted on 200 human subjects. Results demonstrated no potential for dermal irritation or sensitization, supporting the 'hypoallergenic' labeling claim. ## Technological Characteristics Latex patient examination glove; powder-free; beaded cuff. Meets ASTM D3578-91 standards. Protein content < 50 micrograms/gram. Physical properties: Tensile strength > 21 MPa (before aging), > 16 MPa (after aging). ## 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} OCT 11 1996 WRP K953213 # CONTACT PERSON: MR. Y. W. CHOW ## Wembley Rubber Products (M) Sdn Bhd ### Marketing / Factory Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 SEPANG Selangor, Malaysia Telex: MA 39599 WRP Tel: +603-846 1486 Fax: +603-846 1557 ## APPENDIX 4 ### 510 (K) SUMMARY 1. **Trade Name** : COMFIT POWDER FREE LATEX EXAMINATION GLOVES (HYPOALLERGENIC, BEADED, PROTEIN LABELING CONTENT) 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, protein labeling content, 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, protein labeling content, 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 REGISTERED {1} Page 2 of 3 # 7. Summary of Performance data : Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test. | TEST | ASTM D 3578-91 | COMPETIT Powder Free Latex Examination Gloves (Hypo, Beaded, Protein Labeling Content) | | --- | --- | --- | | 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 2.5 | | 2. Length (mm) | | | | Size XS S M L XL | - min 230° min 230 min 230 - | 240 242 238 239 240 | | 3. Palm width (mm) | | | | Size XS S M L XL | - 80 ± 10 95 ± 10 111 ± 10 - | 79 85 96 105 110 | | 4. Thickness (mm) | | | | Finger Palm | min 0.08 min 0.08 | 0.25 0.19 | | 5. Physical Properties | | | | Before Ageing : | | | | Tensile Strength (MPa) Ultimate Elongation (%) | min 21 min 700 | 28.4 873 | | After Ageing : | | | | Tensile Strength (MPa) Ultimate Elongation (%) | min 16 min 500 | 25.8 854 | | 6. Powder Content | - | below 2 mg / glove | | 7. Protein Content | - | below 50 microgram / gram | {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: June 05, 1996 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K953213](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K953213) **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