510(k) K111067
K111067 is an FDA 510(k) premarket notification submitted by Kunshan Jiehong Nonwoven Product Co., Ltd. for the device "JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE". The FDA issued a decision of Substantially Equivalent on August 2, 2011. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Kunshan Jiehong Nonwoven Product Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2011
- Date Received
- April 18, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type