(172 days)
Not Found
No
The device description and intended use clearly define a physical surgical gown made of nonwoven fabric. There is no mention of any software, data processing, or analytical capabilities that would involve AI or ML. The performance studies focus on material properties and barrier protection, not algorithmic performance.
No.
The device is a surgical gown, intended as a protective covering for operating room staff to prevent the transfer of fluids and particulates, which does not fall under the definition of a therapeutic device.
No
Explanation: The device is a surgical gown, which is a protective covering for operating room staff, not a tool used to diagnose medical conditions.
No
The device described is a physical surgical gown made of nonwoven fabric, not software.
Based on the provided text, the Jincheng Surgical Gown is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as a "protective covering, for operating room staff, from the transferring of body fluids and particulates." This describes a physical barrier for personal protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the materials, construction, and styles of a garment. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Use in a laboratory setting for testing
The Jincheng Surgical Gown is a medical device, specifically a personal protective equipment (PPE) item used in a clinical setting.
N/A
Intended Use / Indications for Use
The Jincheng Surgical Gown is a single use, sterile or none sterile (sterile before use) item that is intended to be used in operation room as a protective covering, for operating room staff, from the transferring of body fluids and particulates.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The Jincheng Surgical Gowns are an open back gown manufactured from nonwoven fabric that the fibres are mechanically bonded together. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They come with three different types of materials (SMS polypropylene fabric, Spunlace fabric, and SFT fabric) and four different design styles (regular, reinforced, regular with guider, and reinforced with guider). Therefore there are total eight different models involved in this submission. They are:
Jincheng SMS Gowns
SMS Reinforced Gown
SMS Reinforced Gown with Guider
Jincheng Spunlace Gowns
Spunlace Regular Gown
Spunlace Regular Gown with Guider
Spunlace Reinforced Gown
Spunlace Reinforced Gown with Guider
Jincheng SFT Gowns
SFT Gown
SFT Gown with Guider
Each design has four different sizes: Medium (M), Large (L), Extra Large (XL), and Extra Extra Large (XXL).
All gowns come with sterile and non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room staff / Operation room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Jincheng Surgical Gowns met all relevant requirements in the test standards, and are comparable to the predicate device.
Biocompatibility Studies:
- Cytotoxicity (ISO10993-5): No Toxic Effect
- Skin Irritation and Sensitization (ISO 10993-10): No Effect
Performance Testing:
- Hydrostatic Pressure: Water Resistance (AATCC Test Method 127: 1998)
- Impact Penetration Test : Water Resistance (AATCC 42: 2007)
- Breaking Strength (ASTM D5034: 2008)
- Elmedorf Tear (In house method similar to ASTM - D5734-95:2001)
- Flammability (16 CFR 1610)
- Lint (ISO 9073-10)
Key Results: Jincheng Surgical Gown meet requirements per AATCC Test Method 127: 1998. AATCC 42: 2007, ASTM D5034, 16 CFR 1610, ISO 9073-10, ISO 10993-5, and ISO 10993-10. It is safe and effective, and its performance meets the requirements of its predefined acceptance criteria and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Section 5: 510k Summary
MAR 1 1 2011
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
Hangzhou Jincheng Medical Supplier Manufacture Co., Ltd 202 Zhangshan Road, Renhe Town, Yuhang District Hangzhou, Zhejiang Province, China 311107 Tel: 86-571-86396888 EXT 8205 Submitter's FDA Registration Number: N/A
US Agent and Contact Person
Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: June 22, 2010
Name of Device: Surgical Gown Classification Name: Gown, Surgical Product Code: FYA Regulation Number: 807.4040
Predicate Device Information:
- (1) K052550, "International Medsurp Connection Surgical Gowns (IMC Gowns)", manufactured by "International Medsurp Connection Surgical Gown Inc" located in Schaumburg, Illinois.
- (2) K070431, Welmed Surgical Gowns, manufactured by Welmed, Inc. located in Grayslake, Illinois.
Device description:
The Jincheng Surgical Gowns are an open back gown manufactured from nonwoven fabric that the fibres are mechanically bonded together. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They come with three different types of materials (SMS polypropylene fabric, Spunlace fabric, and SFT fabric) and four different design styles (regular, reinforced, regular with guider, and
Section 5: 510k Summary Section 5 p 1
1
Section 5: 510k Summary
reinforced with guider). Therefore there are total eight different models involved in this submission. They are:
Jincheng SMS Gowns
- . SMS Reinforced Gown
- . SMS Reinforced Gown with Guider
Jincheng Spunlace Gowns
- Spunlace Regular Gown .
- Spunlace Regular Gown with Guider .
- . Spunlace Reinforced Gown
- Spunlace Reinforced Gown with Guider .
Jincheng SFT Gowns
- . SFT Gown
- SFT Gown with Guider .
Each design has four different sizes: Medium (M), Large (L), Extra Large (XL), and Extra Extra Large (XXL).
All gowns come with sterile and non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Intended Use:
The Jincheng Surgical Gown is a single use, sterile or none sterile (sterile before use) item that is intended to be used in operation room as a protective covering, for operating room staff, from the transferring of body fluids and particulates.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Comparison to Predicate Devices
Hangzhou Jincheng Surgical Gowns are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K052550, "International Medsurp Connection Surgical Gowns (IMC Gowns)", manufactured by "International Medsurp Connection Surgical Gown Inc" located in Schaumburg, Illinois.
- (2) K070431, Welmed Surgical Gowns, manufactured by Welmed, Inc. located in Grayslake, Illinois.
2
Section 5: 510k Summary
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Our Device | Predicate Device 1
(K070431) | Predicate Device 2
(K052550) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------------------------|
| Indication for
Use | Are used as protective
covering for operating room
staff, from the transferring of
body fluids and particulates. | Same | Same |
| Basic Design | Full length, constructed with
raglan sleeves, neck closures,
and waist closures. | Same | Same |
| Additional
Features | Regular and reinforced | Information not available | Regular and reinforced |
| Materials/size | Non-woven (SMS, Spunlace,
SFT)/various size | Non-woven (SMS,
SPP)/various size | Non-woven (various
material)/various size |
| Single Use | Yes | Yes | Information not available |
| Sterile | Both sterile and non sterile | Both sterile and non sterile | Information not available |
i
Table 5.1: Comparison of Intended Use, Design, and Material
3
Section 5: 510k Summary
The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Jincheng Surgical Gowns met all relevant requirements in the test standards, and are comparable to the predicate device.
Details of the test procedures and results can be found in Sections 15 (Biocompatibility) and 18 (Performance Testing-Bench).
| Description | Our Device | Predicate Device 1
(K070431) | Predicate Device 2
(K052550) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Cytotoxicity | No Toxic Effect
(ISO10993-5) | No Toxic Effect
(ISO10993-5) | No Toxic Effect
(ISO10993-5) |
| Skin
Irritation and
Sensitization | No Effect
(ISO 10993-10) | No Effect
(ISO 10993-10) | No Effect
(ISO 10993-10) |
| Hydrostatic
Pressure:
Water
Resistance | AATCC Test Method 127: 1998:
Water Resistance: Hydrostatic
Pressure Test | Same | Same |
| Impact
Penetration
Test : Water
Resistance | AATCC 42: 2007: Water
Resistance: Impact Penetration
Test | Same | Same |
| Breaking
Strength | ASTM D5034: 2008: Standard
Test Method for Breaking
Strength and Elongation of
Textile Fabrics (Grab Test) | Same | Same |
| Elmedorf
Tear | In house method similar to
ASTM - D5734-95:2001 | ASTM - D5734-95:2001
Standard Test Method for
Tearing Strength of
Nonwoven Fabrics by
Falling-Pendulum
(Elmendorf) Apparatus | N/A |
| Flammability | 16 CFR 1610: Flammability Test
Method (CPSC CS-191-53)
Standard for Flammability of
Clothing Textiles | Same | Same |
| Lint | ISO 9073-10: Lint and Other
Particles Generation in the Dry
State | Same | IST 160.1 |
Table 5.2: Comparison of Biocompatibility and Performance Testing
4
Section 5: 510k Summary
More details of non-clinical tests are summarized in Section 15 and Section 18.
A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:
Jincheng Surgical Gown meet requirements per AATCC Test Method 127: 1998. AATCC 42: 2007, ASTM D5034, 16 CFR 1610, ISO 9073-10, ISO 10993-5, and ISO 10993-10. It is safe and effective, and it's performance meets the requirements of its predefined acceptance criteria and intended uses.
A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Substantial Equivalent Statement
Based on the comparison of intended use, design, materials, and performance, our Jincheng Surgical Gowns are substantial equivalent to its predicate devices.
5
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hangzhou Jincheng Medical Supplier Manufacture Company, Limited C/O Mr. Chengyu Shen Manton Business and Technology Services 5 Carcy Street Pennington, New Jersey 08534
MAR 1 1 2011
Re: K102692
Trade/Device Name: Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: February 17, 2011 Received: February 18, 2011
Dear Mr. Shen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2- Mr. Shen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that IFDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
James Rotch
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital. Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
7
Section 4: Indications for Use
| Material | Design | Sterilization | Model Name | Sizes |
|---|---|---|---|---|
| SMS | Reinforced | Sterile | SG74100 | M, L, XL, XXL |
| Non-sterile | SG74700 | M, L, XL, XXL | ||
| SMS | Reinforced with Guider | Sterile | SG78100 | M, L, XL, XXL |
| Non-sterile | SG78700 | M, L, XL, XXL | ||
| Spunlace | Regular | Sterile | SG80100 | M, L, XL, XXL |
| Non-sterile | SG80700 | M, L, XL, XXL | ||
| Spunlace | Regular with Guider | Sterile | SG82100 | M, L, XL, XXL |
| Non-sterile | SG82700 | M, L, XL, XXL | ||
| Spunlace | Reinforced | Sterile | SG84100 | M, L, XL, XXL |
| Non-sterile | SG84700 | M, L, XL, XXL | ||
| Spunlace | Reinforced with Guider | Sterile | SG88100 | M, L, XL, XXL |
| Non-sterile | SG88700 | M, L, XL, XXL | ||
| SFT | Gown | Sterile | SG94100 | M, L, XL, XXL |
| Non-sterile | SG94700 | M, L, XL, XXL | ||
| SFT | Gown with Guider | Sterile | SG98100 | M, L, XL, XXL |
| Non-sterile | SG98700 | M, L, XL, XXL |
The gowns involved in this submission are summarized in the Table below:
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Elijah T. Clemmons Williams | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
| 510(k) Number: | K102692 |
|---|---|
| ---------------- | --------- |
Section 4: Indication Section 4 page 2Section 4: Indication Section 4 page