ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W— 510(k) K000217
Substantially EquivalentShield Gloves Manufacturer (M) Sdn Bhd
FDA 510(k) clearance K000217 for ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W, Substantially Equivalent on 2000-02-18. 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
- Sparks, NV, US
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More clearances from Shield Gloves Manufacturer (M) Sdn Bhd
view all- K011613 — POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
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- K992418 — ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI
- K992419 — ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR
Data sourced from openFDA. This site is unofficial and independent of the FDA.