← Product Code [KGO](/productcode/KGO) · K960407 # COMFIT ORTHOPEDIC (K960407) _Wembley Rubber Products (M) Sdn Bhd · KGO · Apr 26, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K960407 ## Device Facts - **Applicant:** Wembley Rubber Products (M) Sdn Bhd - **Product Code:** [KGO](/productcode/KGO.md) - **Decision Date:** Apr 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## 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 Natural rubber latex surgeon glove; powdered with absorbable dusting powder; hypoallergenic. Features 0.30 mm minimum thickness at finger and palm to resist damage from bone, screws, wires, or surgical instruments. Used in clinical and operating room settings by healthcare personnel to provide a protective barrier against patient fluids, waste, and environmental contaminants. ## Clinical Evidence Clinical data from a Modified Draize test on 200 human subjects demonstrated no potential for dermal irritation or sensitization, supporting the 'hypoallergenic' labeling claim. ## Technological Characteristics Natural rubber latex; powdered with absorbable dusting powder; 0.30 mm minimum thickness at finger/palm. Meets ASTM D3577-91 standards for physical properties and dimensions. Watertight integrity tested per FDA 1000 ml requirements. ## 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. ## 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} K960407 WRP APR 26 1996 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 # 510 (K) SUMMARY 1. **Trade Name** : COMFIT ORTHOPAEDIC, BROWN BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) 2. **Common Name** : Surgeon Gloves 3. **Classification Name** : Surgeon Glove 4. **Substantial Equivalence** : Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91. 5. **Description of device** : Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91. COMFIT ORTHOPAEDIC brown surgical gloves are 0.30 mm (minimum) thick single wall at finger and palm areas to reduce damage from contacting bone, screws, wires or instruments. 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 {1} Page 2 Of 3 # 7. Summary of Performance data : Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test. | TEST | | ASTM D 3577-91 | COMFIT ORTHOPAEDIC Brown Beaded Surgeon's Gloves (Powdered,Hypo) | | --- | --- | --- | --- | | 1. Watertight (1000 ml) | | S-4,AQL 1.5 | Pass based on AQL of 1.0 | | 2. Length (mm) | | | | | Size | 5.5 | min 245 | 260 | | | 6.0 | min 265 | 265 | | | 6.5 | min 265 | 265 | | | 7.0 | min 265 | 270 | | | 7.5 | min 265 | 293 | | | 8.0 | min 265 | 293 | | | 8.5 | min 265 | 293 | | | 9.0 | min 265 | 293 | | 3. Palm width (mm) | | | | | Size | 5.5 | 70 ± 6 | 72 | | | 6.0 | 76 ± 6 | 77 | | | 6.5 | 83 ± 6 | 83 | | | 7.0 | 89 ± 6 | 89 | | | 7.5 | 95 ± 6 | 94 | | | 8.0 | 102 ± 6 | 102 | | | 8.5 | 108 ± 6 | 108 | | | 9.0 | 114 ± 6 | 114 | | 4. Thickness (mm) | | | | | Finger | | min 0.10 | 0.36 | | Palm | | min 0.10 | 0.31 | | 5. Physical Properties | | | | | Before Ageing : | | | | | Tensile Strength (MPa) | | min 24 | 29.29 | | Ultimate Elongation (%) | | min 750 | 890 | | After Ageing : | | | | | Tensile Strength (MPa) | | min 18 | 28.38 | | Ultimate Elongation (%) | | min 560 | 852 | {2} 6. **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 3577-91. 7. **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”. 8. **Conclusion** This glove exceeds the ASTM D 3577-91 requirements, meet pinhole FDA requirements, meet Hypoallergenic labeling claim. Date Summary Prepared: January 20, 1996 Page 3 of 3 --- **Source:** [https://fda-staging.innolitics.com/device/K960407](https://fda-staging.innolitics.com/device/K960407) **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