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FDA 510(k)

BALDUR LATEX EXAMINATION GLOVES

K-Number: K923707 · 1992-11-17

ApplicantHti Trading Group
Decision Date1992-11-17
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BALDUR LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Hti Trading Group. It received FDA 510(k) clearance on 1992-11-17 under 510(k) number K923707. 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 BALDUR LATEX EXAMINATION GLOVES?

BALDUR LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1992-11-17. The listed applicant is Hti Trading Group. The 510(k) number is K923707.

When did BALDUR LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

BALDUR LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 1992-11-17, under 510(k) number K923707.

Who is the listed applicant for BALDUR LATEX EXAMINATION GLOVES?

The FDA 510(k) record lists Hti Trading Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BALDUR LATEX EXAMINATION GLOVES?

The FDA product code for BALDUR LATEX EXAMINATION GLOVES is LYY.

Related Clinical Trials

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.

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Other records listing Hti Trading Group 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.

K963441BALDUR VINYL POWDERED GLOVESK902644BALDUR LATEX EXAMINATION 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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