(289 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of surgical gowns, with no mention of AI or ML technology.
No.
The device is a surgical gown, intended for protection against microorganisms and fluids during surgical procedures, not for treating or diagnosing a disease or condition.
No
Explanation: The device is a surgical gown, which is a protective apparel used to prevent the transfer of microorganisms and fluids during surgical procedures. It does not perform any diagnostic function.
No
The device is a surgical gown, which is a physical, disposable medical device made of textile materials. The description focuses on material properties, physical construction, and barrier performance, with no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the surgical gown is for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and materials of the gown, not on any components or processes related to testing samples from the human body.
- Performance Studies: The performance studies listed are related to the physical properties of the fabric (air permeability, flammability, water resistance, strength, etc.) and biocompatibility (cytotoxicity, irritation, sensitization). These are relevant to a protective garment, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical gown does not fit that definition.
N/A
Intended Use / Indications for Use
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification.
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AG series surgical gowns met the requirements for Level 3 classification.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The Surgical Gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relabler for further packaging and Ethylene Oxide (EO) sterilization.
The subject device includes six models, which are provided in Table 1 Model List. The six models have the same product size, the only difference is whether the surgical gown has an inside reinforcement and material of the reinforcement. AG1001 and AE1001 don't have the reinforcement. AG2001 and AE2001 have an inside trapezoidal fabric-reinforcement on the chest and two sleeves of the gown. AG3001 and AE3001 have an inside rectangular poly-reinforcement on the chest and two sleeves of the gown.
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 personnel / operating 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)
Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
- ASTM D737-04 (2016) Standards Test Method for Air Permeability of Textile Fabrics
- 16 CFR 1610: 2008 Standard for the Flammability of Clothing Textiles
- AATCC 127:2003 Water Resistance: Hydrostatic Pressure Test
- AATCC 42:2007 Water Resistance: Impact Penetration Test
- ISO 9073-10:2003 Textiles- Test Method for Nonwovens- Part 10: Lint and Other Particles Generation in the Dry State
- ASTM D1683-11 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
- ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 13, 2018
GMAX Industries, Inc. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.Box 120-119 Shanghai, 200120 Cn
Re: K172987
Trade/Device Name: Surgical Gown (AE1001, AE2001, AE3001) Surgical Gown (AG1001, AG2001, AG3001) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: June 20, 2018 Received: June 22, 2018
Dear Diana Hong:
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172987
Device Name Surgical Gown (AE1001, AE2001, AE3001)
Indications for Use (Describe)
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSVAAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K172987
Device Name Surgical Gown (AG1001, AG2001, AG3001)
Indications for Use (Describe)
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSVAAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AG series surgical gowns met the requirements for Level 3 classification.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K172987
-
- Date of Preparation: 7/12/2018
- Sponsor Identification 2.
GMAX Industries, Inc.
2150 joshuas path, suite 205, Hauppauge, NY 11788
Contact Person: Julia Huang Position: Sales Manager Tel: 631-348-4050 ext 101 Fax: 630-348-4357 Email: Julia.huang@gmaxind.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 3609253199 Email: info@mid-link.net
5
4. Identification of Subject Device
Trade Name:
Surgical Gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) Common Name: Gown, Surgical
Regulatory Information Classification Name: Gown, Surgical Classification: II Product Code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General& Plastic Surgery
Indications for Use for AE series:
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification.
Indications for Use for AG series:
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AG series surgical gowns met the requirements for Level 3 classification.
Device Description
The Surgical Gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relabler for further packaging and Ethylene Oxide (EO) sterilization.
The subject device includes six models, which are provided in Table 1 Model List. The six models have the same product size, the only difference is whether the surgical gown has an inside reinforcement and material of the reinforcement. AG1001 and AE1001 don't have the reinforcement. AG2001 and AE2001 have an inside trapezoidal fabric-reinforcement on the chest and two sleeves of the gown. AG3001 and
6
| Table 1 Model List | |||
|---|---|---|---|
| Model | Size | Style | AAMI level |
| AG1001 | XL | Non-reinforced | 3 |
| AG2001 | XL | Fabric-reinforced | 3 |
| AG3001 | XL | Poly-reinforced | 3 |
| AE1001 | XL | Non-reinforced | 2 |
| AE2001 | XL | Fabric-reinforced | 2 |
| AE3001 | XL | Poly-reinforced | 2 |
AE3001 have an inside rectangular poly-reinforcement on the chest and two sleeves of the gown.
- న్. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K043585 Product Name: Medline Eclipse™ Surgical Gown Manufacturer: MEDLINE INDUSTRIES, INC.
Predicate Device 2 510(k) Number: K120192 Product Name: Disposable Surgical Gowns Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
- Non-Clinical Test Conclusion
-
A ASTM D737-04 (2016) Standards Test Method for Air Permeability of Textile Fabrics
-
16 CFR 1610: 2008 Standard for the Flammability of Clothing Textiles
-
AATCC 127:2003 Water Resistance: Hydrostatic Pressure Test
-
AATCC 42:2007 Water Resistance: Impact Penetration Test
-
ISO 9073-10:2003 Textiles- Test Method for Nonwovens- Part 10: Lint and Other Particles Generation in the Dry State
-
ASTM D1683-11 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
-
A ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
-
ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in vitro
7
Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization
-
- Clinical Test Conclusion
No clinical study is included in this submission.
8
Substantially Equivalent (SE) Comparison 8.
| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | SE Assessment |
|---|---|---|---|---|
| Product Code | FYA | FYA | FYA | Same |
| Regulation Number | 878.4040 | 878.4040 | 878.4040 | Same |
| Indications for Use | Surgical gown is intended to be | |||
| worn by operating room | ||||
| personnel during surgical | ||||
| procedure to protect both the | ||||
| surgical patient and the operating | ||||
| room personnel from transfer of | ||||
| microorganisms, body fluids, and | ||||
| particulate material. | ||||
| Per ANSI/AAMI PB70:2012 | ||||
| Liquid barrier performance and | ||||
| classification of protective | ||||
| apparel and drapes intended for | ||||
| use in health care facilities, the | ||||
| AE series surgical gowns met the | ||||
| requirements for Level 2 | ||||
| classification, the AG series | ||||
| surgical gowns met the | ||||
| requirements for Level 3 | ||||
| classification. | Medline Disposable EclipseTM | |||
| Surgical Gowns are surgical | ||||
| apparel 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 | ||||
| body fluids, micro-organisms, | ||||
| and particulate material. | Disposable Surgical Gowns, | |||
| which are blue colored and EO | ||||
| sterilized, are indicated 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. It culd achieve Level 3 | ||||
| Barrier Performance as per AAMI | ||||
| PB70:2003. It is for single use | ||||
| only. | Similar |
Table 2 Comparison of Technology Characteristics
9
| Style | | Non-reinforced/
Fabric-reinforced/
Poly-reinforced | Non-reinforced/
Fabric-reinforced/
Poly-reinforced | Reinforced | Same | |
|-------------------------------------|--------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|--------------------------------|--|
| Size | | XL | L, XL,XXL | M, L, XL, XXL | See note below
Difference 1 | |
| Physical
specification | Barrier
protection
level | Level 2/Level 3 per AAMI PB70 | Level 2 per AAMI PB70 | Level 3 per AAMI PB70 | Same | |
| | Tearing
strength | >30N | Not known | Not known | See note below
Difference 2 | |
| | Fire
protection | Class I | Not known | Class I | Same | |
| | Lint: | $Log_{10}30 ft3/min/ft2 | Not known | Not known | | |
| Mechanical | Tensile
strength | ≥20N | Not known | ≥20N | Same | |
| specifications | Durability | Disposable | Disposable | Disposable | Same | |
| Material | | SMMMS, Polypropylene, PE
(Poly Ethylene), Polyester | SMS | SMS, SPP, Polypropylene, PE,
Nylon, Polyester | See note below
Difference 4 | |
| Biocompatibility | | Under the conditions of the study, the device is non-toxic, | Under the conditions of the study, the device is non-toxic, | Under the conditions of the study, the device is non-toxic, | Same | |
| non-irritating,
non-sensitizing. | and | non-irritating,
non-sensitizing. | and | non-irritating,
non-sensitizing. | and | |
10
Difference 1
The subject devices only have one size of XL, while the predicate device 1 has three kinds of sizes which are L. XL, XXL, and the predicate device 2 has four kinds of device which are M, L, XL, XXL. The difference in the size will not affect the function. So the difference in the size will not affect the safety and effectiveness of the subject device.
Difference 2
Although the tearing strength of the predicate devices are unknown, the subject device is large enough for safety using. Therefore this different will not raise new safety and effectiveness questions.
Difference 3
Although the linting level of the predicate devices are unknown, the linting levice is acceptable for safety using. Therefore this different will not raise new safety and effectiveness questions.
Difference 4
The main material of the subject device is SMMS, and the Predicate Device 1 and Predicate Device 2 is SMS, the difference between the material of the subject devices is the amounts of the meltblown layers. Therefore, this difference will not affect the substantially equivalency of the subject device.