MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
FDA 510(k) clearance K982694 · decided 1998-12-14
Clearance details
- K-number
- K982694
- Device name
- MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-03
- Decision date
- 1998-12-14
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mundelein, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTG recall (Z-1563-2026) | Medline Industries, LP | 2026-03-12 |