(268 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of a disposable surgical isolation gown, with no mention of AI or ML technology.
No.
This device is a surgical isolation gown, intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material, not to provide therapy.
No
The device is a disposable surgical isolation gown intended to protect against the transfer of microorganisms, body fluids, and particulate material. It is a protective barrier, not a tool for diagnosing medical conditions.
No
The device description clearly outlines a physical garment made of non-woven fabric and PE film, with physical fasteners and cuffs. The testing described focuses on material properties and barrier performance, not software functionality.
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 gown is for protecting patients and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the physical construction and materials of the gown, designed for physical protection.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Testing: The performance testing described focuses on barrier properties, flammability, strength, and biocompatibility – all relevant to a protective garment, not an IVD.
Therefore, the Disposable Surgical Isolation Gown is a medical device, but it falls under the category of protective apparel, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
Product codes
FYC
Device Description
The disposable surgical isolation gown consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings,The products are composed of 45g of SMS (spunbond, meltblown, spunbond) non-woven fabric and 20g of PE(Polyethylene) film layer material with the color in blue.Disposable surgical isolation gown have a hook and loop fastener at the back of the neck and a waist ties feature to secure the gown to the body of the user. The material of the collar of the Disposable Surgical Isolation Gown is 35g of white PP (polypropylene). The cuffs are white polyester rib sleeve cloth with a length of 7.5cm. The disposable surgical isolation gown provided in ONE product model in six sizes. The size of disposable surgical isolation gown is divided into six groups: S, M, L, XL, XXXL. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical isolation gown meet the requirements for Level 4 classification.
The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
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
patients and health care 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
Non-clinical tests were conducted to verify that the proposed device met all design specifications as to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes:
- A ASTM- F2407-20 Standard Specification for Surgical Gowns intended for Use in Healthcare Facilities
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles.
-
ASTM F1671/F1671M-2013 Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne.
-
AATCC 42-2017e-Water Penetration Resistance:Impact Penetration Test.
-
AATCC 127-2017(2018)-Water Resistance:Hydrostatic Pressure Test.
-
ISO 9073-10:2004 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State.
- A ASTM D1683/D1683M:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics.
-
ASTM D5733:1999 Standard Test Method For Tearing Strength of Nonwoven Fabrics By The Trapezoid Procedure.
-
ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test).
-
ASTM D737:2018 Standard Test Method for Air Permeability of Textile Fabrics.
-
ASTM D3776/D3776M-09a(2017) Basis Weight-Mass Per Unit Area (Weight) of Fabric.
-
ASTM F1868–17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate.
-
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 results: All tests were passed.
Biocompatibility evaluation and test:
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and ISO10993-1:2018 supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- A In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- 》 Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices —Part 10: Tests for irritation and skin sensitization
-
Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 29, 2022
Crown Name Disposable Hygiene Products Fty.Ltd. % Doris Chen Regulatory Affairs Staff Shanghai Jiushun Enterprise Management Technology Service Co Room 1502,BaoAn Buiding,No.800 Dongfang Road Shanghai, 200122 China
Re: K212422
Trade/Device Name: Disposable Surgical Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: March 28, 2022 Received: April 1, 2022
Dear Doris Chen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212422
Device Name Disposable Surgical Isolation Gown Model:CN302
Indications for Use (Describe)
The Disposable Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K212422
This summary of 510(k) safety and effectiveness information is being submitted in accordance
with the requirements of 21 CFR 807.92.
The assigned 510(k) Number: K212422
Summary Prepared Date:March 28, 2022
Submitter Information 1.
- � Sponsor Name: Crown Name Disposable Hygiene Products Fty. Ltd.
- Address: Chengbei Industrial Zone,Zhucheng Ave,Xinzhou District,Wuhan,Hubei, � 431400,CHINA.
- Contact Person (including title): Ying Fang (Manger) �
- � Phone:+86-27-82761940
- � Fax: +86-27-82761339
2. Submission Correspondent:
- Contact Person: Doris Chen �
- � Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.
- � Address: Room 1502,BaoAn Buiding,No.800 Dongfang Road,Shanghai,China.
- Tel: +86-21-50931939 �
- � Email: doris-chen@isosh.com
3. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Surgical Apparel |
| Trade Name: | Disposable Surgical Isolation Gown |
| Classification Name: | Gown, Isolation, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FYC |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
4
4. Predicate Device Information
Predicate Device
| Sponsor: | Yanbian Pacific Textile Co., LTD |
|---|---|
| Common Name: | Surgical Apparel |
| Trade Name: | Surgical Isolation Gown |
| 510(k) number: | K203415 |
| Review Panel: | General Hospital |
| Product Code: | FYC |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: |
Device Description 5.
The disposable surgical isolation gown consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings,The products are composed of 45g of SMS (spunbond, meltblown, spunbond) non-woven fabric and 20g of PE(Polyethylene) film layer material with the color in blue.Disposable surgical isolation gown have a hook and loop fastener at the back of the neck and a waist ties feature to secure the gown to the body of the user. The material of the collar of the Disposable Surgical Isolation Gown is 35g of white PP (polypropylene). The cuffs are white polyester rib sleeve cloth with a length of 7.5cm. The disposable surgical isolation gown provided in ONE product model in six sizes. The size of disposable surgical isolation gown is divided into six groups: S, M, L, XL, XXXL. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical isolation gown meet the requirements for Level 4 classification.
The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
6. Intended Use / Indications for Use
The Disposable Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not
Crown Name Disposable Hygiene Products Fty.Ltd.
5
intended for use in the operating room. In addition, the disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
Comparison with predicate device 7.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Crown Name Disposable Hygiene | ||
| Products Fty.Ltd. | Yanbian Pacific Textile Co., | ||
| LTD | -- | ||
| Product Name | Disposable Surgical Isolation Gown | Surgical Isolation Gown | -- |
| K Number | K212422 | K203415 | -- |
| Product Code | FYC | FYC | Same |
| Regulation | |||
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Intended use/ | |||
| Indications for | |||
| Use | The Disposable Surgical Isolation | ||
| Gown is intended to protect patients | |||
| and health care personnel from the | |||
| transfer of microorganisms, body | |||
| fluids and particulate material. Not | |||
| intended for use in the operating | |||
| room. In addition, the disposable | |||
| surgical isolation gown meets the | |||
| requirements of a Level 4 barrier | |||
| protection per ANSI/AAMI | |||
| PB70:2012 -Liquid Barrier | |||
| Performance and Classification of | |||
| Protective Apparel Drapes Intended | |||
| for Use in Health Care Facilities. | |||
| The disposable surgical isolation | |||
| gown is a single use, disposable | |||
| medical device provided non-sterile. | The Surgical Isolation | ||
| Gown is intended to protect | |||
| patients and health care | |||
| personnel from the transfer | |||
| of microorganisms, body | |||
| fluids and particulate | |||
| material. Not intended for | |||
| use in the operating room. | |||
| In addition, the Surgical | |||
| Isolation Gown meets the | |||
| requirements of an AAMI | |||
| Level 3 barrier protection | |||
| for an isolation gown per | |||
| ANSI/AAMI PB70:2012 | |||
| Liquid Barrier Performance | |||
| and Classification of | |||
| Protective Apparel Drapes | |||
| Intended for Use in Health | |||
| Care Facilities (ANSI/AAMI | |||
| PB70). The Surgical | |||
| Isolation Gown is a single | |||
| use, disposable medical | |||
| device provided non-sterile | Similar | ||
| Barrier | |||
| protection | |||
| level | Level 4 per AAMI PB 70 | Level 3 per AAMI PB 70 | Different |
| Note 1 | |||
| Gown Style | Hook and loop Closure,Belt Tie, | ||
| Elastic Cuffs | Tape Neck Closure ,Belt | ||
| Tie,Elastic Cuffs | Similar | ||
| Note 3 | |||
| Durability | Disposable | Disposable | Same |
| OTC Use | Yes | Yes | Same |
| Sterile | No | No | Same |
| Size | S, M, L, XL, XXL, XXXL. | S, M, L, XL, XXL, 3XL, 4XL | Similar |
| Color | Blue | Blue | Same |
| Material | |||
| Composition | SMS Nonwoven, Polyethylene, | ||
| Polyester, Polypropylene, Nylon | SMS PP + PE non-woven | ||
| fabric material | Similar | ||
| Note 2 | |||
| Weight per | |||
| square (g) | |||
| (ASTM D3776) | 66g/m² | 60.7g/m² (1.79 oz/yd2) | Similar |
| Note 3 | |||
| Flammability | |||
| (16 CFR Part |
-
| Class I
(Results obtained from Three Lots) | Class I | Same |
| | (Results obtained from Three Lots)
Hydrostatic Pressure(cm)
:>50cm H2O
(AATCC-127) | Hydrostatic Pressure(cm)
:>50cm H2O
(AATCC-127) | Same |
| Liquid Barrier | Water Impact (g): ≤1.0g
(AATCC-42) | Water Impact (g): ≤1.0g
(AATCC-42) | Same |
| Performance
(AAMI PB70) | Resistance by Blood-Borne
Pathogen:
1: Base Material: Pass
2:Seam:Pass
3:Sleeve seam:Pass
Assay titer (PFU/mL):All were 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles.
-
ASTM F1671/F1671M-2013 Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne.
-
AATCC 42-2017e-Water Penetration Resistance:Impact Penetration Test.
-
AATCC 127-2017(2018)-Water Resistance:Hydrostatic Pressure Test.
-
ISO 9073-10:2004 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State.
- A ASTM D1683/D1683M:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics.
-
ASTM D5733:1999 Standard Test Method For Tearing Strength of Nonwoven Fabrics By The Trapezoid Procedure.
-
ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test).
-
ASTM D737:2018 Standard Test Method for Air Permeability of Textile Fabrics.
-
ASTM D3776/D3776M-09a(2017) Basis Weight-Mass Per Unit Area (Weight) of Fabric.
-
ASTM F1868–17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate.
-
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.
10
| Test item | Proposed device | Acceptance criteria | Results |
|---|---|---|---|
| Weight per | |||
| square (g) | |||
| (ASTM D3776) | 3 non-consecutive lots tested | ||
| Lot A: 66.88 g/m² | |||
| Lot B: 67.86 g/m² | |||
| Lot C: 66.92g/m² | ≥65g/m² | Pass | |
| Flammability | |||
| (16 CFR Part 1610) | Class1 | ||
| 3 non-consecutive lots tested | Class 1:Burn | ||
| time≥3.5 | |||
| seconds | Pass | ||
| Liguid Barrier | |||
| Performance | |||
| AATCC-127 | 3 non-consecutive lots tested, using a | ||
| sample size of 32/lot. | |||
| Hydrostatic Pressure(cm) :>50cm H2O | Hydrostatic | ||
| Pressure(cm) : |
50cm H2O | Pass |
| Liguid Barrier
Performance
(AATCC-42) | 3 non-consecutive lots tested, using a
sample size of 32/lot.
Water Impact (g): ≤1.0g | Water Impact
(g): ≤1.0g | Pass |
| Liguid Barrier
Performance
(ASTMF1671/F1671M
-2013) | 3 non-consecutive lots tested, using a
sample size of 32/lot.
Resistance t by Blood-Borne
Pathogen:
1: Base Material: Pass
2:Seam:Pass
3:Sleeve seam:Pass
Assay titer (PFU/mL):All were Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices—
Part 10: Tests for irritation and skin sensitization.
| Item | Proposed device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is | |
| noncytotoxic. | Pass | |
| Irritation | Under the conditions of the study, the device is | |
| nonirritating. | Pass | |
| Sensitization | Under the conditions of the study, the device is | |
| nonsensitizing | Pass |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
12
10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device,
Disposable Surgical Isolation Gown is as safe, as effective, and performs as well as or better
than the legally marketed predicate device, Surgical Isolation Gown(K203415).