MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS— 510(k) K964142
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K964142 for MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS, Substantially Equivalent on 1997-02-25. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
Recent devices under product code KKX
view allMore clearances from Medline Industries, Inc.
view all- DEN210049 — Medline ART Skin Harvesting System
- K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
- K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- K222665 — Medline UNITE® Ankle Fusion Plating System
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Recalls naming K964142
K-number listed on FDA's recall record- Z-1963-2018 — Maximal Barrier Drape; Product Codes: ASK-00001-1A
- Z-2010-2018 — Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
- Z-3079-2017 — MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964142.
Data sourced from openFDA. This site is unofficial and independent of the FDA.