White Nitrile Examination Glove, Sterile With Chemotherapy Drugs Claim

Polymer Patient Examination Glove

Riverstone Resources SDN BHD

The following data is part of a premarket notification filed by Riverstone Resources Sdn Bhd with the FDA for White Nitrile Examination Glove, Sterile With Chemotherapy Drugs Claim.

Pre-market Notification Details

• Device ID: K180452
• 510k Number: K180452
• Device Name: White Nitrile Examination Glove, Sterile With Chemotherapy Drugs Claim
• Classification: Polymer Patient Examination Glove
• Applicant: Riverstone Resources SDN BHD Lot 56, No 15, Jalan Jasmin 2 Bukit Beruntung, MY 48300
• Contact: Suresh Kumar
• Correspondent: Suresh Kumar; Riverstone Resources SDN BHD Lot 56, No 15, Jalan Jasmin 2 Bukit Beruntung, MY 48300
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-20
• Decision Date: 2018-06-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10075289715447	K180452	000
10075289715430	K180452	000
10075289715423	K180452	000
10075289715416	K180452	000
10075289715409	K180452	000
10075289715393	K180452	000
10075289715386	K180452	000