SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES— 510(k) K994248
Substantially EquivalentShinemound Enterprise, Inc.
FDA 510(k) clearance K994248 for SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES, Substantially Equivalent on 2000-01-28. Applicant: Shinemound Enterprise, Inc.. Device class: 1.
Clearance details
- Applicant
- Shinemound Enterprise, Inc.
- Product code
- Code LYZ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Billerica, MA, US
Recent devices under product code LYZ
view allMore clearances from Shinemound Enterprise, Inc.
view all- K051913 — POWDERED LATEX PATIENT EXAMINATION GLOVES
- K994258 — SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
- K993231 — SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
- K993240 — SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
- K971360 — SYNTEX
Data sourced from openFDA. This site is unofficial and independent of the FDA.