Non-Sterile, PF Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs-Blue

Patient Examination Glove, Specialty

YTY Industry (Manjung) Sdn Bhd

The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn Bhd with the FDA for Non-sterile, Pf Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs-blue.

Pre-market Notification Details

• Device ID: K182383
• 510k Number: K182383
• Device Name: Non-Sterile, PF Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs-Blue
• Classification: Patient Examination Glove, Specialty
• Applicant: YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir Sitiawan, MY 32020
• Contact: Punitha Samy
• Correspondent: Punitha Samy; YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir Sitiawan, MY 32020
• Product Code: LZC
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-31
• Decision Date: 2019-03-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20686864069045	K182383	000
20686864042123	K182383	000
20686864042260	K182383	000
20686864042390	K182383	000
20686864042536	K182383	000
00686864059547	K182383	000
00686864059493	K182383	000
20686864029001	K182383	000
20686864039017	K182383	000
20686864049023	K182383	000
20686864059039	K182383	000
20686864041980	K182383	000