Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate— 510(k) K221626

Substantially Equivalent

Jr Engineering & Medical Technologies (M) Sdn. Bhd.

FDA 510(k) clearance K221626 for Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate, Substantially Equivalent on 2022-12-07. Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
Product code
Code LZA
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Hulu Selangor, MY
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.