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FDA 510(k)

REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE

K-Number: K951908 · 1995-09-01

ApplicantRegent Hospital Products
Decision Date1995-09-01
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Regent Hospital Products. It received FDA 510(k) clearance on 1995-09-01 under 510(k) number K951908. 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 REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE?

REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Regent Hospital Products. The 510(k) number is K951908.

When did REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE receive FDA 510(k) clearance?

REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE received FDA 510(k) clearance on 1995-09-01, under 510(k) number K951908.

Who is the listed applicant for REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE?

The FDA 510(k) record lists Regent Hospital Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE?

The FDA product code for REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE is KGO.

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Other records listing Regent Hospital Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910928RUBBER LATEX SURGEONS GLOVESK902601REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMSK896432RUBBER LATEX SURGEON'S GLOVEK891658REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES

Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

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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