HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)— 510(k) K994432
Substantially EquivalentHwa Teh Industrial Sdn. Bhd.
FDA 510(k) clearance K994432 for HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS), Substantially Equivalent on 2000-02-16. Applicant: Hwa Teh Industrial Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Hwa Teh Industrial 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
- Batang Berjuntai, MY
Recent devices under product code LYY
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- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
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More clearances from Hwa Teh Industrial Sdn. Bhd.
view all- K010803 — POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
- K000725 — HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
- K992810 — HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
- K992730 — HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
- K896251 — HWA TEH EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.