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FDA 510(k)

REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS

K-Number: K902601 · 1990-08-10

ApplicantRegent Hospital Products
Decision Date1990-08-10
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS 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 1990-08-10 under 510(k) number K902601. 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 DIAG PROCED GLOVES HYPOALLERG CLAIMS?

REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS is a medical device that received FDA 510(k) clearance on 1990-08-10. The listed applicant is Regent Hospital Products. The 510(k) number is K902601.

When did REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS receive FDA 510(k) clearance?

REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS received FDA 510(k) clearance on 1990-08-10, under 510(k) number K902601.

Who is the listed applicant for REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS?

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 DIAG PROCED GLOVES HYPOALLERG CLAIMS?

The FDA product code for REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS 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 GLOVESK896432RUBBER LATEX SURGEON'S GLOVEK891658REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES

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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