PATIENT EXAMINATION GLOVES (LATEX)— 510(k) K892789
Substantially EquivalentP.T. Indo Rama Synthetics
FDA 510(k) clearance K892789 for PATIENT EXAMINATION GLOVES (LATEX), Substantially Equivalent on 1989-07-14. Applicant: P.T. Indo Rama Synthetics. Device class: 1.
Clearance details
- Applicant
- P.T. Indo Rama Synthetics
- 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
- Jakarta Indonesia, ID
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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Data sourced from openFDA. This site is unofficial and independent of the FDA.