(240 days)
No
The device is a surgical gown and the description focuses on materials and physical properties, with no mention of AI or ML.
No.
The surgical gown is intended to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate material, not to treat or alleviate a medical condition.
No
The document describes surgical gowns, which are protective barriers used in surgical settings, not devices used to diagnose medical conditions.
No
The device described is a physical surgical gown, not a software-only medical device. The description focuses on materials, construction, and physical performance testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the materials and construction of the gown, which are relevant to its barrier properties, not to any diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies listed are bench tests related to the physical properties and protective capabilities of the gown (biocompatibility, hydrostatic pressure, penetration resistance, etc.), not diagnostic accuracy or performance.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This surgical gown does not perform any such function.
N/A
Intended Use / Indications for Use
Jiangsu Guangda's Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.
Product codes
FYA
Device Description
Jiangsu Guangda's Disposable XLarge Reinforced Surgical Gowns, Model Number GD-SG-01, are made from SMS fabrics and PE + PP two layer compound protective reinforcement with 100% white Terylene cuffs to provide user protection in surgical settings.
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
surgical patients and operating room personnel
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
The information in the Premarket Notification on safety and efficiency supports a finding of substantially equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, material, design and testing methods.
The predicate, GRI MEDICAL Surgical Gowns (K102652) met acceptance criteria for bench testing including biocompatibility, hydrostatic pressure, impact penetration, Resistance to Penetration by Synthetic Blood, flammability, and strength via tensile, tear and seam strength.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K121152
Section 5: 510(k) Summary
April 12, 2012 1. Preparation Date:
DEC 1 2 2012
2. Submitted by:
Jiangsu Guangda Medical Material Co., Ltd. 18 BaoChang Road North, LiBao Town, Haian County, Jiangsu Province, China 226631 Owner/Operator #: 10023676 Registration Number: 3006847952
3. Contact Person/Prepared by:
Darren Reeves (804) 307-7706 Phone: Fax: (866) 393-4954 Email: dreeves@dpdconline.com
4. Device Identification:
Trade Name: Surgical Gown Common Name: Gown, Surgical Classification: Surgical Apparel, FYA, Class 2 (878.4040)
GRI MEDICAL Surgical Gowns (K102652) 5. Predicate Device:
6. Device Description:
Jiangsu Guangda's Disposable XLarge Reinforced Surgical Gowns, Model Number GD-SG-01, are made from SMS fabrics and PE + PP two layer compound protective reinforcement with 100% white Terylene cuffs to provide user protection in surgical settings.
7. Intended Use:
Jiangsu Guangda's Reinforced Surgical Gowns, Model Number GD-SG-01, are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.
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8. Comparison to Predicate:
The following table shows similarities and differences between the predicate identified in Section 5 of this summary. There are no significant differences between the Jiangsu Guangda's Gowns, Model Number GD-SG-01, and their respective predicate products.
| | Item | Proposed Device: Jiangsu Guangda's Gowns,
Model Number GD-SG-01 | Predicate Device: GRI MEDICAL
Surgical Gowns (K102652) |
|-----------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Product Code | FYA, Class II | FYA, Class II |
| | Intended Use | Jiangsu Guangda's Reinforced Surgical Gowns are
non-sterile, single use surgical gowns intended to
protect surgical patients and operating room
personnel from the transfer of microorganisms,
body fluids, and particulate material.
This product may be sterilized using Ethylene
Oxide (EO) following the validation and routine
control under ANSI/AAMI/ISO 11135. | GRI's Non Reinforced, Film Reinforced, and
Fabric Reinforced Surgical Gowns are
sterile and non-sterile, single use surgical
gowns intended to protect surgical patients
and operating room personnel from the
transfer of microorganisms, body fluids,
and particulate material. |
| | Style | Reinforced | Reinforced and non-reinforced |
| | Durability | Disposable | Disposable |
| | Size | XL | Various |
| | Color | Blue | Various |
| | Material | SMS and PE+PP two layer compound | Same |
| | Weight per square | 45 g/m² | 50 g/m² |
| | Label and Labeling | Conforms to FDA Requirements | Unknown |
| Liquid Barrier Performance:
ANSI/AAMI PB70 | Hydrostatic Pressure: AATCC
Test Method 127 | All were >20 | Has met acceptance criteria |
| | Impact Penetration: AATCC Test
Method 42 | All were ≤1 | Has met acceptance criteria |
| | Resistance by Blood-Borne
Pathogen: ASTM- F1671 | All were ≤1 | Unknown |
| | Resistance by Synthetic Blood:
ASTM- F1670 | Passed | Has met acceptance criteria |
| Physical Specifications | Breaking Strength: ASTM-
D5034 | Passed | Has met acceptance criteria |
| | Tearing Strength: ASTM- D5733 | Passed | Has met acceptance criteria |
| | Flammability Test Method (16
CFR 1610) | Class I | Has met acceptance criteria |
| | Seam Strength: ASTM- D1683 | Passed | Has met acceptance criteria |
| Biocompatibility:
ISO 10993-1 | Cytotoxicity: ISO 10993-5 | Passed | Has met acceptance criteria |
| | Irritation: ISO 10993-10 | Passed | Has met acceptance criteria |
| | Sensitization: ISO 10993-10 | Passed | Has met acceptance criteria |
| Sterilization | Method | Although sold non-sterile, gowns can be EO
Sterilized | Unknown |
| | EO and ECH Residual | Conforms to ISO 10993-7 | Unknown |
Jiangsu Guangda Medical Material Co., Ltd. Document Number K121152 S3.1
Page 4 of 7
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9. Summary of Testing:
The information in the Premarket Notification on safety and efficiency supports a finding of substantially equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, material, design and testing methods.
| Standard or Guidance | Data Generated | Relevant Section of
Submission |
|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------|
| ASTM-F2407-06 Standard Specification for Surgical Gowns intended for Use in Healthcare Facilities | Biocompatibility Testing Evaluation | 15 |
| AAMI/ANSI/ISO 10993-1:2003(E), Biological evaluation of
medical devices -- Part 1: Evaluation and testing | Biocompatibility Testing
Evaluation | 15 |
| AAMI/ANSI/ISO 10993-5:2009, Biological evaluation of medical
devices -- Part 5: Tests for In Vitro cytotoxicity | Cytotoxicity | 15 |
| AAMI/ANSI/ISO 10993-10:2010, Biological evaluation of
medical devices -- Part 10: Tests for irritation and sensitization | Skin Irritation, intra-
cutaneous reactivity &
sensitization | 15 |
| ANSI/AAMI PB70:2003, Liquid Barrier Performance and
Classification of protective apparel and drapes intended for use
in health care facilities | Barrier Performance | 18 |
| AATCC Test Method 127-2007&2008 Hydrostatic Pressure:
Option 2 | Water Resistance | 18 |
| AATCC Test Method 42-2007 Impact Penetration: Type II | Water Resistance | 18 |
| ASTM-F1671:2007 Standard Test Method for Resistance of
Materials Used in Protective Clothing to Penetration by Blood-
Borne Pathogens | Resistance to Penetration | 18 |
| ASTM-F1670:2008 Standard Test Method for Resistance of
Materials Used in Protective Clothing to Penetration by
Synthetic Blood | Resistance to Penetration | 18 |
| ASTM-D5034:1995 Standard Test Method for Breaking
Strength and Elongation of Textile Fabrics (Grab Test) | Tensile Strength | 18 |
| ASTM-D5733:1999 Standard Test Method for Tearing Strength
of Nonwoven Fabrics by Trapezoid Procedure | Tearing Strength | 18 |
| ASTM-D1683:2007 Standard Test Method for Failure in Sewn
Seams of Woven Apparel Fabrics | Seam Strength Test | 18 |
| CPSC CS-191-53 Flammability Test Method (16 CFR 1610)
Standard for Flammability of Clothing Textiles | Flammability | 18 |
Test Data Provided in this Submission
The predicate, GRI MEDICAL Surgical Gowns (K102652) met acceptance criteria for bench testing including biocompatibility, hydrostatic pressure, impact penetration, Resistance to Penetration by Synthetic Blood, flammability, and strength via tensile, tear and seam strength.
10. Conclusion:
The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is is demonstrated through intended use, materials, design and testing methods.
- Similarities/Differences of the proposed device when compared to the predicate: The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S.
Jiangsu Guangda Medical Material Co., Ltd. Document Number K121152 S3.1
Page 5 of 7
P. 3 of 3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 12, 2012
Mr. Darren Reeves Jiangsu Guangda Medical Material Company, Limited 7305 Hancock Village Drive, Suite 109 CHESTERFIELD VA 23832
Re: K121152
Trade/Device Name: Jiangsu Guangda Surgical Gown, Model Number GD-SG-01 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 30, 2012 Received: December 4, 2012
Dear Mr. Reeves:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a reward your 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 conninered pror to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic Act (110.) that to neviee, subject to the general controls provisions of the Act. The 1 ou may, therefore, market 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 addition. I lease noter a, 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 IT your device is blassified (been to be subjecting major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Reeves
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthong Dr. ant
Anthony D. Watson, B.A., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo includes an emblem on the left and the text "Department of Health and Human Services" on the right. The emblem appears to be a stylized representation of an eagle or other bird.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Indications for Use
510(k) Number (if known): K121152
Device Name: Jiangsu Guangda Surgical Gown, Model Number GD-SG-01
Indications for Use:
Jiangsu Guangda's Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
Elizabeth F. Claverie
2012.12.11 18:08:11 -05'00'
General Hospital Anesthesfolog Infection Control, Denta
510(k) Number: K121152