ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O— 510(k) K991743
Substantially EquivalentShield Gloves Manufacturer (M) Sdn Bhd
FDA 510(k) clearance K991743 for ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O, Substantially Equivalent on 1999-06-23. 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
- Crofton, MD, 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
- K000156 — SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
- K000217 — ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
- K992417 — ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
- K992418 — ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI
Recalls naming K991743
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991743.
Data sourced from openFDA. This site is unofficial and independent of the FDA.