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FDA 510(k)

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential

K-Number: K191860 · 2020-03-31

ApplicantSemperit Technische Produkte Gesellchaft M.B.H.
Decision Date2020-03-31
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is a medical device manufactured by Semperit Technische Produkte Gesellchaft M.B.H.. It received FDA 510(k) clearance on 2020-03-31 under approval number K191860. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by Semperit Technische Produkte Gesellchaft M.B.H.. The 510(k) number is K191860.

When was Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential approved by the FDA?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential received FDA 510(k) clearance on 2020-03-31, under approval number K191860.

What company makes Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is manufactured by Semperit Technische Produkte Gesellchaft M.B.H..

What is the FDA product code for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

The FDA product code for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is KGO.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40724559 Exposure to Per- and Polyfluoroalkyl Substances (PFASs) in Healthcare: Environmental and Clinical Insights. Life (Basel, Switzerland) (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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