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FDA 510(k)

MALA LATEX EXAM GLOVES AND SCAN-SUB

K-Number: K946154 · 1995-01-11

ApplicantLowenkamp Intl., Inc.
Decision Date1995-01-11
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MALA LATEX EXAM GLOVES AND SCAN-SUB is the device name listed in this FDA 510(k) record. The listed applicant is Lowenkamp Intl., Inc.. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K946154. 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 MALA LATEX EXAM GLOVES AND SCAN-SUB?

MALA LATEX EXAM GLOVES AND SCAN-SUB is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Lowenkamp Intl., Inc.. The 510(k) number is K946154.

When did MALA LATEX EXAM GLOVES AND SCAN-SUB receive FDA 510(k) clearance?

MALA LATEX EXAM GLOVES AND SCAN-SUB received FDA 510(k) clearance on 1995-01-11, under 510(k) number K946154.

Who is the listed applicant for MALA LATEX EXAM GLOVES AND SCAN-SUB?

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

What is the FDA product code for MALA LATEX EXAM GLOVES AND SCAN-SUB?

The FDA product code for MALA LATEX EXAM GLOVES AND SCAN-SUB is LYY.

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Other records listing Lowenkamp Intl., 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.

K951940PATIENT EXAMINATION GLOVEK910439FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM)K903513SANOFLEX-STERILE LATEX SURGICAL 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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