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FDA 510(k)

AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX)

K-Number: K891298 · 1989-03-29

ApplicantMedi Tex, Inc.
Decision Date1989-03-29
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX) is the device name listed in this FDA 510(k) record. The listed applicant is Medi Tex, Inc.. It received FDA 510(k) clearance on 1989-03-29 under 510(k) number K891298. 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(TM) PATIENT EXAMINATION GLOVE (LATEX)?

AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX) is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Medi Tex, Inc.. The 510(k) number is K891298.

When did AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX) receive FDA 510(k) clearance?

AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX) received FDA 510(k) clearance on 1989-03-29, under 510(k) number K891298.

Who is the listed applicant for AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX)?

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

What is the FDA product code for AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX)?

The FDA product code for AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX) 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 Medi Tex, 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.

K923901LATEX EXAMINATION GLOVESK901116STERILE LATEX PATIENT EXAMINATION GLOVESK840944INFUSION NEEDLE IIPN

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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