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FDA 510(k)

DYNATEX PATIENT EXAMINATION GLOVES (LATEX)

K-Number: K891797 · 1989-04-28

ApplicantAzteca Intl., Inc.
Decision Date1989-04-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DYNATEX PATIENT EXAMINATION GLOVES (LATEX) is the device name listed in this FDA 510(k) record. The listed applicant is Azteca Intl., Inc.. It received FDA 510(k) clearance on 1989-04-28 under 510(k) number K891797. 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 DYNATEX PATIENT EXAMINATION GLOVES (LATEX)?

DYNATEX PATIENT EXAMINATION GLOVES (LATEX) is a medical device that received FDA 510(k) clearance on 1989-04-28. The listed applicant is Azteca Intl., Inc.. The 510(k) number is K891797.

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

DYNATEX PATIENT EXAMINATION GLOVES (LATEX) received FDA 510(k) clearance on 1989-04-28, under 510(k) number K891797.

Who is the listed applicant for DYNATEX PATIENT EXAMINATION GLOVES (LATEX)?

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

What is the FDA product code for DYNATEX PATIENT EXAMINATION GLOVES (LATEX)?

The FDA product code for DYNATEX PATIENT EXAMINATION GLOVES (LATEX) is LYY.

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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

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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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