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FDA 510(k)

REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES

K-Number: K891658 · 1989-06-06

ApplicantRegent Hospital Products
Decision Date1989-06-06
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES 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 1989-06-06 under 510(k) number K891658. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES?

REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES is a medical device that received FDA 510(k) clearance on 1989-06-06. The listed applicant is Regent Hospital Products. The 510(k) number is K891658.

When did REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES receive FDA 510(k) clearance?

REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES received FDA 510(k) clearance on 1989-06-06, under 510(k) number K891658.

Who is the listed applicant for REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES?

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 D(TM) NON-STERILE DENTAL GLOVES?

The FDA product code for REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES is LYY.

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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.

K951908REGENT BIOGEL LATEX-FREE SURGEON'S GLOVEK910928RUBBER LATEX SURGEONS GLOVESK902601REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMSK896432RUBBER LATEX SURGEON'S GLOVE

Related Devices (Code: LYY)

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.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company LimitedK230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn BhdK223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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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