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FDA 510(k)

STERILE LATEX EXAM GLOVES

K-Number: K894676 · 1989-08-17

ApplicantSuperior Healthcare Group, Inc.
Decision Date1989-08-17
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE LATEX EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Superior Healthcare Group, Inc.. It received FDA 510(k) clearance on 1989-08-17 under 510(k) number K894676. 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 STERILE LATEX EXAM GLOVES?

STERILE LATEX EXAM GLOVES is a medical device that received FDA 510(k) clearance on 1989-08-17. The listed applicant is Superior Healthcare Group, Inc.. The 510(k) number is K894676.

When did STERILE LATEX EXAM GLOVES receive FDA 510(k) clearance?

STERILE LATEX EXAM GLOVES received FDA 510(k) clearance on 1989-08-17, under 510(k) number K894676.

Who is the listed applicant for STERILE LATEX EXAM GLOVES?

The FDA 510(k) record lists Superior Healthcare Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE LATEX EXAM GLOVES?

The FDA product code for STERILE LATEX EXAM GLOVES is LYY.

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Other records listing Superior Healthcare Group, Inc. 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.

K925530INSTRUMENT WARMERK924764OVERTUBE FOR ENDSCOPIC LIGATORK905755NON-STERILE PATIENT EXAMINATION GLOVESK903347SODIUM CHLORIDE SOLUTIONK904216STERILE WATER SOLUTION CATALOG # 10000K903340STERILE URETHRAL CATHETER PROCEDURE KITS

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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

View on FDA Database →

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

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