ROYALSHIELD NON-STERILE POWDER-FREE— 510(k) K945031
Substantially EquivalentShield Gloves Manufacturer (M) Sdn Bhd
FDA 510(k) clearance K945031 for ROYALSHIELD NON-STERILE POWDER-FREE, Substantially Equivalent on 1995-01-11. Applicant: Shield Gloves Manufacturer (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Shield Gloves Manufacturer (M) Sdn Bhd
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Petaling Jaya, MY
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- K992417 — ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.