JR.MEDIK Latex Surgeons Gloves Powder Free— 510(k) K192328
Substantially EquivalentJr Engineering & Medical Technologies (M) Sdn. Bhd.
FDA 510(k) clearance K192328 for JR.MEDIK Latex Surgeons Gloves Powder Free, Substantially Equivalent on 2020-03-10. Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Hulu Selangor, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.