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FDA 510(k)

Blue Latex Examination Powder Free Gloves

K-Number: K192329 · 2019-11-25

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2019-11-25
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Blue Latex Examination Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K192329. 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 Blue Latex Examination Powder Free Gloves?

Blue Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K192329.

When did Blue Latex Examination Powder Free Gloves receive FDA 510(k) clearance?

Blue Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2019-11-25, under 510(k) number K192329.

Who is the listed applicant for Blue Latex Examination Powder Free Gloves?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Latex Examination Powder Free Gloves?

The FDA product code for Blue Latex Examination Powder Free Gloves is LYY.

Other records listing Jr Engineering & Medical Technologies (M) Sdn. Bhd. 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.

K222350Sterile Nitrile Surgical Gloves Powder FreeK221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl CitrateK222348JR MEDICK221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackK222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)K221157JR Medic

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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