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FDA 510(k)

EASY TOUCH LATEX EAM GLOVES

K-Number: K920174 · 1992-04-22

ApplicantSimpex, Inc.
Decision Date1992-04-22
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EASY TOUCH LATEX EAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Simpex, Inc.. It received FDA 510(k) clearance on 1992-04-22 under 510(k) number K920174. 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 EASY TOUCH LATEX EAM GLOVES?

EASY TOUCH LATEX EAM GLOVES is a medical device that received FDA 510(k) clearance on 1992-04-22. The listed applicant is Simpex, Inc.. The 510(k) number is K920174.

When did EASY TOUCH LATEX EAM GLOVES receive FDA 510(k) clearance?

EASY TOUCH LATEX EAM GLOVES received FDA 510(k) clearance on 1992-04-22, under 510(k) number K920174.

Who is the listed applicant for EASY TOUCH LATEX EAM GLOVES?

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

What is the FDA product code for EASY TOUCH LATEX EAM GLOVES?

The FDA product code for EASY TOUCH LATEX EAM GLOVES is LYY.

Related Clinical Trials

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Other records listing Simpex, 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.

K913793SIMPEX INC. ORAL AND RECTAL THERMOMETERSK913794SIMPEX INC. SURGICAL DRESSINGK911452FIXATION PINK911505FIXATION WIRE

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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