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FDA 510(k)

AMBIDERM

K-Number: K971102 · 1997-08-29

ApplicantSupertex Industrial, S.A. DE C.V.
Decision Date1997-08-29
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMBIDERM is the device name listed in this FDA 510(k) record. The listed applicant is Supertex Industrial, S.A. DE C.V.. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K971102. 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 AMBIDERM?

AMBIDERM is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Supertex Industrial, S.A. DE C.V.. The 510(k) number is K971102.

When did AMBIDERM receive FDA 510(k) clearance?

AMBIDERM received FDA 510(k) clearance on 1997-08-29, under 510(k) number K971102.

Who is the listed applicant for AMBIDERM?

The FDA 510(k) record lists Supertex Industrial, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMBIDERM?

The FDA product code for AMBIDERM is LYY.

Related Clinical Trials

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Other records listing Supertex Industrial, S.A. DE C.V. 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.

K963866AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)K962737AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)

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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