(460 days)
Not Found
No
The device is a physical isolation gown and the summary describes its material, construction, and performance testing against standards for barrier protection. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is an isolation gown intended to provide barrier protection, not to treat or prevent a disease in a therapeutic sense.
No
Explanation: The device is an isolation gown intended to provide barrier protection and does not perform any diagnostic functions.
No
The device description clearly states it is a physical isolation gown made of nonwoven SMS material, designed to provide a physical barrier. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, treatment, or prevention of disease.
- Intended Use: The intended use of the Paneffort AAMI Level 3 Isolation Gowns is to provide barrier protection for healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a specimen.
- Device Description: The description details the physical characteristics and materials of the gown, not components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the barrier properties and material characteristics of the gown (liquid barrier, tensile strength, tear resistance, etc.), not on the accuracy or reliability of a diagnostic test.
The device is clearly described as a medical device (specifically a surgical isolation gown) intended for personal protective equipment (PPE) in a healthcare setting. It does not perform any diagnostic function on biological specimens.
N/A
Intended Use / Indications for Use
The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAMI Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
Product codes (comma separated list FDA assigned to the subject device)
FYC
Device Description
The Paneffort AAMI Level 3 Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. The Paneffort AAMI Level 3 Isolation Gown is a single use, disposable medical device provided non-sterile. Paneffort AAMI Level 3 Isolation Gown is offered in one color (blue) and six different sizes of Small, Medium, Regular/Large, X-Large, 2X-Large, and 3X-Large. Each model is constructed of a nonwoven Spunbond-Meltblown-Spunbond (SMS) material that is tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.
The Paneffort AAMI Level 3 Isolation Gown consists of one critical zone throughout the entire gown including seams, but excluding cuffs, hems, and bindings as per AAMI PB70:2012. It is a protective tape sealed gown along with other design features like tieneck, elastic cuffs, and belt tie, that meets AAMI PB70 Level 3 barrier performance for protective apparel.
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
healthcare personnel in isolation applications
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 Testing:
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
- AAMI ANSI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities
- ASTM D3776/D3776/D3776M-2020 Test Methods for Mass Per Unit Area (Weight) of Woven Fabric
- ASTM D5034-09(2013)- Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D5587-08- Standard Test Method for Tearing Strength of Fabrics by Trapezoid
- AATCC 127-2017 Water Resistance: Hydrostatic Pressure Test
- AATCC 42:2018 -Water Resistance: Impact Penetration Test
- ISO 9073 Part 10: 2003 (for non-woven fabric) Lint and other particles generation in the dry state (Lint Generation test)
- ASTM D737-18 Standard Test Method for Air Permeability of Textile Fabrics
- ASTM D1683/D1683M-11a Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
- ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
- 16 CFR Part 1610-2008 Standard for the Flammability of Clothing
- ISO 13938-2:2019 Pneumatic method for determination of bursting strength and bursting distension
Testing summary (sample size and key results):
- Bursting Strength: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: ≥ 40 kPa (≥5.80 psi). Conclusion: The test meets the Acceptance Criteria.
- Basis Weight: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: ≥35 g/m2. Conclusion: The test meets the Acceptance Criteria.
- Linting Test: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: Co-coefficient of Linting ≤4.2. Conclusion: The test meets the Acceptance Criteria.
- Air Permeability: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: ≥15 ft3/min/ft2. Conclusion: The test meets the Acceptance Criteria.
- Water Resistance: Hydrostatic Pressure: Paneffort AAMI Level 3 Isolation Gown, 3 lots (Lot 1: 74 pieces; Lot 2: 72 pieces; Lot 3: 72 pieces). Acceptance criteria: ≥ 50cm H2 O (Ac: 3, Re: 4); AQL: 4% (Level 3 ANSI/AAMI PB70:2012). Conclusion: The test meets the Acceptance Criteria (some samples failed but within AQL).
- Water Resistance: Impact Penetration: Paneffort AAMI Level 3 Isolation Gown, 3 lots (Lot 1: 74 pieces; Lot 2: 72 pieces: Lot 3: 72 pieces). Acceptance criteria: ≤1.0g (Ac: 3, Re: 4); AQL: 4% (Level 3 ANSI/AAMI PB70:2012). Conclusion: The test meets the Acceptance Criteria.
- Tensile Strength/Breaking Strength: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: ≥30N (≥7 lbf). Conclusion: The test meets the Acceptance Criteria.
- Tearing Strength: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: ≥10N (≥2.3 lbf). Conclusion: The test meets the Acceptance Criteria.
- Seam Strength: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: ≥30N (≥7 lbf). Conclusion: The test meets the Acceptance Criteria.
- Flammability: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: Class I. Textile exhibiting normal flammability. Conclusion: The test meets the Acceptance Criteria.
- Water Vapour resistance: Paneffort AAMI Level 3 Isolation Gown, 32 samples each from 3 different lots. Acceptance criteria: 0,0-1,0 kPa.m2 / W. Conclusion: The test meets the Acceptance Criteria.
Biocompatibility Testing:
Biocompatibility tests were performed as per the ISO 10993-1:2018 Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process. The In-Vitro cytotoxicity, Skin irritation and Skin sensitization parameters were tested as per the below standards:
- ISO 10993-5:2009 Biological Evaluation of Medical Device, Part 5-Tests for In Vitro cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization
The Paneffort AAMI Level 3 Isolation gowns passed biocompatibility studies per ISO-10993.
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 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2022
Paneffort, LLC % Shilpa Gampa Delivery Manager and US Agent Freyr Solutions 150 College Rd W #102 Princeton, New Jersey 08540
Re: K212717
Trade/Device Name: Paneffort AAMI Level 3 Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: October 19, 2022 Received: October 20, 2022
Dear Shilpa Gampa:
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.
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
1
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 medical devices and radiation-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 -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212717
Device Name Paneffort AAMI Level 3 Isolation Gown
Indications for Use (Describe)
The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAM Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
| 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)
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3
510(k) Summary – K212717 Paneffort AAMI Level 3 Isolation Gown
1. Submitter Information:
| Application Correspondent:
Phone:
E-mail: | Shilpa Gampa
Delivery Manager and US Agent
Freyr Inc.
150 College Rd W #102, Princeton, NJ 08540
+1 908-483-7958 Ext 1780
+1 760-583-4401
usagent@freyrsolutions.com | | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Manufacturer: | Paneffort (Cambodia) Garment Co. Ltd.,
National Road No.2, Kleang Sambatt,
Pot Sar Ward, Bati District,
Takeo 21309, Cambodia | | |
| Specification Developer
& Product Owner | Paneffort, LLC
700 Elmridge Center Drive
Rochester, NY 14626 | | |
| Phone: | +855 12284810 | | |
| Contact Person: | Harry Xu | | |
| E-mail: | Phil@paneffort.com | | |
| Date Prepared: | 28-Nov-2022 | | |
| 2. Device Identification: | | | |
| Device Trade Name: | Paneffort AAMI Level 3 Isolation Gown | | |
| Device Common Name: | Gowns, Isolation, Surgical | | |
| Classification Name: | Surgical Isolation Gown/Surgical Apparels | | |
| Device Class: | Class II | | |
| Regulation Number: | 21 CFR 878.4040 | | |
| Product Code: | EVC | | |
4
Predicate Device:
| Device Name | 510(k) Number |
|---|---|
| PRIMAGARD Isolation Gown | |
| (AAMI PB70 Level 3) | K160361 |
Table 1 List of Predicate Devices
3. Device Description
The Paneffort AAMI Level 3 Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. The Paneffort AAMI Level 3 Isolation Gown is a single use, disposable medical device provided non-sterile. Paneffort AAMI Level 3 Isolation Gown is offered in one color (blue) and six different sizes of Small, Medium, Regular/Large, X-Large, 2X-Large, and 3X-Large. Each model is constructed of a nonwoven Spunbond-Meltblown-Spunbond (SMS) material that is tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.
The Paneffort AAMI Level 3 Isolation Gown consists of one critical zone throughout the entire gown including seams, but excluding cuffs, hems, and bindings as per AAMI PB70:2012. It is a protective tape sealed gown along with other design features like tieneck, elastic cuffs, and belt tie, that meets AAMI PB70 Level 3 barrier performance for protective apparel.
4. Intended Use/Indications for Use
The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAMI Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
5. Device and Predicate Device Technical Characteristics
The fundamental scientific technology, materials of construction and mechanism of operation are identical between the subject Paneffort AAMI Level 3 Isolation Gown and the predicate device. Table 2 summarizes the comparison of technological characteristics between the subject and predicate devices.
5
| S.No. | Parameters | PRIMAGARD Isolation Gown
(AAMI PB70 Level 3)
(Predicate Device) | Paneffort AAMI Level 3 Isolation
Gown
(Subject Device) | Remarks |
|-------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 1. | Manufacturer | Primed Medical Products Inc. | Paneffort (Cambodia) Garment Co. Ltd. | N/A |
| 2. | Product Class
and Code | Class II, FYC | Class II, FYC | Same |
| 3. | 510(k) Number | K160361 | K212717 | N/A |
| 4. | Regulation Number | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| 5. | Intended use/
Indications for use | PRIMAGARD Level 3 Isolation
Gowns are intended to be worn by
healthcare personnel in isolation
applications to provide moderate
barrier protection for health care
personnel and patients from the
transfer of microorganisms, body
fluids, and particulate material.
The PRIMAGARD Isolation
Gowns of this 510(k) meet the
requirements of level 3 Liquid
Barrier Performance as per AAMI
PB70:2012 and are provided non-
sterile and are single use only. | The Paneffort AAMI Level 3 Isolation
Gowns are intended to be worn by
healthcare personnel in isolation
applications to provide moderate barrier
protection for health care personnel and
patients from the transfer of
microorganisms, body fluids, and
particulate material. Paneffort AAMI
Level 3 Isolation Gowns meet the
requirements of level 3 Liquid Barrier
Performance as per AAMI PB70:2012 and
are provided non-sterile and are single use
only. | Same |
| 6. | Level of barrier
protection AAMI PB70 | Level 3 | Level 3 | Same |
| 7. | Material composition | Non-woven Polypropylene
(SMS) | SMS non-woven (polypropylene) | Same |
| 8. | Design | 5 Models:
Apron Neck Closure,
Tape Tab Neck Closure,
Hook and Loop Closure | Tie neck,
Full back,
Elastic cuffs,
Blue belt tie | Similar1 |
| S.No. | Parameters | PRIMAGARD Isolation Gown
(AAMI PB70 Level 3)
(Predicate Device) | Paneffort AAMI Level 3 Isolation
Gown
(Subject Device) | Remarks |
| | | Apron Neck Closure,
Tie Neck Closure | taped seams. | |
| 9. | Color | Blue, Yellow | Blue | Similar² |
| 10. | Sterility | Non-Sterile | Non-Sterile | Same |
| 11. | Use | Single Use | Single Use; Disposable | Same |
| 12. | Basis weight ASTM
D3776 | $39.97 ± 1.61 g/m²$
$(1.17 oz/yd² ± 0.05)$ | Tested to ASTM D3766. Met the
acceptance criteria. | Similar³ |
| 13. | LBP: Hydrostatic
Pressure AATCC 127 | ≥ 50 cm H₂ O | Pass, Met the standard's requirement
(≥ 50 cm H₂ O) | Same |
| 14. | LBP: Impact Penetration
AATCC 42 | ≤ 1 g | Pass, Met the standard's requirement
(≤ 1.0 g) | Same |
| 15. | Flammability: 16 CFR
Part 1610.7 | Class I | Class I | Same |
| 16. | Breaking strength (MD)
ASTM D5034 | Tested to ASTM D5034.
Met acceptance criteria | Tested to ASTM D5034. Met
acceptance criteria | Similar⁴ |
| 17. | Breaking strength (CD)
ASTM D5034 | | | Similar⁵ |
| 18. | Tearing strength (MD)
ASTM D5587-08 | Tested to ASTM D5587.
Met acceptance criteria | Tested to ASTM D5587. Met acceptance
criteria | Similar⁶ |
| 19. | Tearing strength (CD)
ASTM D5587 | | | Similar⁷ |
| 20. | Linting (ISO 9073-10) | Tested to NWSP 160.1 R0 | Met acceptance criteria. | Similar⁸ |
| S.No. | Parameters | PRIMAGARD Isolation Gown
(AAMI PB70 Level 3)
(Predicate Device) | Paneffort AAMI Level 3 Isolation
Gown
(Subject Device) | Remarks |
| 21. | Seam Strength | Tested to ASTM D5035.
Met acceptance criteria. | Tested to ASTM D5035. Met
acceptance criteria. | Similar9 |
| 22. | Thermal and
Evaporative Resistance
ASTM F1868 | Tested to ASTM F1868
PART C.
Met acceptance criteria | Tested to ASTM F1868 PART
C.
Met acceptance criteria | Similar10 |
| 23. | Air Permeability
ASTM D737 | Tested to ASTM D737.
Met acceptance criteria. | Tested to ASTM D737. Met acceptance
criteria. | Similar11 |
| 24. | Irritation | Under the conditions of the study,
not an irritant. | Under the conditions of the study, not an
irritant. | Same |
| 25. | Sensitization | Under the conditions of the study,
not a sensitizer. | Under the conditions of the study, not a
sensitizer. | Same |
| 26. | Cytotoxicity | Under the conditions of the study
the device is non-cytotoxic. | Under the conditions of the study the
device is non-cytotoxic. | Same |
Table 2 Technological Characteristics Comparison of Proposed device and Predicate device
6
7
Note:
N/A –refers that the section is Not applicable/ available.
Similar': The subject device design is sinilar to the additional features. The additional features do not raise related the safety and effectiveness of the device. Performance testing includion has been performed on the final finished device which includes all construction materials and color additives.
Similar': The subject device is offered only in single color while the predicate is offered in both Blue and Yellow colors. Peformance testing including biocompatibility evaluation has been the final finished device which includes all construction materials and color additives. Therefore, the difference does not raise any questions on the safety and effectiveness of the device.
Sinitar': The gowns were tested using the ASTM D3776 standard test method. As there linits for this test, we compared the test values obtained with a similar FDA approved (K203415) device. The test values for predicate and subject were less than the when evel
8
Traditional 510(k) Paneffort AAMI Level 3 Isolation Gown
device, so we considered the difference in basis as acceptable. Therefore, the difference does not raise any gressions related to the safety and effectiveness of the device.
Similar' and Similar': The subject devices were tested for Breaking Strength using the ASTM F2407 recommended ASTM DS134 test nethod. The breaking strength of subject device differed from the recommended range of the ASTM P2407 Standard Specification for Sugical Gowns Intended for Use in Healthcare Facilities. The difference does not raise any questions on the safety and effectiveness of the device.
Similar and Similar : The subject devices were tested for Breaking Strength using the ASTM F2407 recommended ASTM D5887 test nethod. The tearing strength of the subject than the predicates, but it is within the recommended range of the ASTM F2407 for Surgical Gowns Intended for Use in Healthere, the difference does not raise any questions related to the safety and efectiveres of the device. Similar: Both the subject device and Predicate device were to the Gown using different test nethods of ASTM D1683/D1683M-11 a and ASTM D5035, respectively. Here, the Subject device to test method jielded the values within the recommended range of the ASTM F240 Standard Specification for Surgical Gowns Intented for Use in Healther. While the Predicate device was tested according to ASTM D505, which specifically utilizes cut strip test proce and elong force and elongation of most textile fabrics within the recommended range of the ASTM F2407 Standard Specification. As both the performed to indicate the durability of the fabric within the acceptable ranges, the difference does not raise any questions on the safety and effectiveness of the device.
Similar": Both the subject device were tested for Lint generation using the ISO 9073-10 standard recommended test nethod. As per the annicable ISO testing standard, there is no acception to Linting, However, the standard states that devending on the choice of particle counter, the size ranges can fall within of 0.3 um or 0.5 um. As test values obtained were within this particle size limit, the difference does not raise any questions related to the safety and effectiveness of the device.
Similar": Both the subject device and Predicted for Thermal and Euporative Resistance using the ASTM F1868-17 test nethod. As per the ASTM F1868 standard, the acceptance criteria are was evaporative resistance neasured for the speciment (that includes the test specinen (fabriches in test plate covered with a ligated. There are no acceptance criteria for the Reserver, as bath the gowns vere tested as per the applicable standard mot raise any questions related to the safety and effectiveness of the device.
Similar": Both the subject device and Predicty were tested for Air Permeability using the ASTM D737 est method. There is no minimum performance expectation for the air permeability parameter and Ashation gowns. Therefore, the difference does not ruise any questions related to the safety and effectiveness of the device.
9
6. Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
-
- ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
-
- AAMI ANSI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities
-
- ASTM D3776/D3776/D3776M-2020 Test Methods for Mass Per Unit Area (Weight) of Woven Fabric
-
- ASTM D5034-09(2013)- Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D5587-08- Standard Test Method for Tearing Strength of Fabrics by ર. Trapezoid
-
- AATCC 127-2017 Water Resistance: Hydrostatic Pressure Test
-
- AATCC 42:2018 -Water Resistance: Impact Penetration Test
- ISO 9073 Part 10: 2003 (for non-woven fabric) Lint and other particles generation 8. in the dry state (Lint Generation test)
-
- ASTM D737-18 Standard Test Method for Air Permeability of Textile Fabrics
-
- ASTM D1683/D1683M-11a Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
-
- ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
-
- 16 CFR Part 1610-2008 Standard for the Flammability of Clothing
-
- ISO 13938-2:2019 Pneumatic method for determination of bursting strength and bursting distension
The test summary table mentioned below includes the brief information for all the ASTM F2407-20 - Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities recommended tests that demonstrates the performance of Level 3 Isolation gowns.
10
| S.
No | Test Performed | Device Description/ Sample
Size | Test Methods/ Standards applicable | Acceptance
criteria | Unexpected
results/
Significant
deviations | Conclusion |
|----------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 1. | Bursting
Strength | Paneffort AAMI Level 3
Isolation Gown,
32 samples each from 3
different lots | ASTM D3786 Standard Test Method for Bursting
Strength of Textile Fabrics | ≥ 40 kPa (≥5.80 psi) | None | The test meets the
Acceptance
Criteria |
| 2. | Basis Weight | Paneffort AAMI Level 3
Isolation Gown
32 samples each from 3
different lots | ASTM D3776 / D3776M - 20 :
Standard Test Methods for Mass Per Unit Area
(Weight) of Fabric; Method C | ≥35 g/m2 | None | The test meets the
Acceptance
Criteria |
| 3. | Linting Test | Paneffort AAMI Level 3
Isolation Gown
32 samples each from 3
different lots | ISO 9073-10:2003:
Test methods for nonwovens - Part 10: Lint and
other particles generation in the dry state | Co-coefficient of
Linting ≤4.2 | None | The test meets the
Acceptance
Criteria |
| 4. | Air
Permeability | Paneffort AAMI Level 3
Isolation Gown
32 samples each from 3
different lots | ASTM D737-18:
Standard Test Method for Air Permeability of
Textile Fabrics | ≥15 ft3/min/ft2 | None | The test meets the
Acceptance
Criteria |
| 5. | Water
Resistance:
Hydrostatic
Pressure | Paneffort AAMI Level 3
Isolation Gown,
3 lots
Lot 1: 74 pieces;
Lot 2: 72 pieces;
Lot 3: 72 pieces. | AATCC 127-2018:
Test Method for Water Resistance: Hydrostatic
Pressure | ≥ 50cm H2 O (Ас:
3, Re: 4);
AQL: 4% (Level 3
ANSI/
AAMI PB70:2012) | In Lot 1, three
samples (out
of 32) failed the
test.
In Lot 2, three
samples (out
of 32) failed the
test. In Lot 3, two
samples (out of 32
samples) failed
the test. | The test meets the
Acceptance
Criteria |
| 6. | Water
Resistance:
Impact
Penetration | Paneffort AAMI Level 3
Isolation Gown,
3 lots
Lot 1: 74 pieces;
Lot 2: 72 pieces:
Lot 3: 72 pieces | AATCC 42-2017
Test Method for Water Resistance: Impact
Penetration | ≤1.0g (Ac: 3, Re:
4);
AQL: 4% (Level 3
ANSI/
AAMI PB70:2012) | None | The test meets the
Acceptance
Criteria |
| 7. | Tensile
Strength/
Breaking
Strength | Paneffort AAMI Level 3
Isolation Gown,
32 samples each from 3
different lots | ASTM D5034-09 (2013):
Standard Test Method for Breaking Strength and
Elongation of Textile Fabrics (Grab Test) | ≥30N (≥7 lbf). | None | The test meets the
Acceptance
Criteria |
| 8. | Tearing
Strength | Paneffort AAMI Level 3
Isolation Gown,
32 samples each from 3
different lots | ASTM D5587-08,
Option 1: Standard Test Method for Tearing
Strength of Fabrics by Trapezoid Procedure | ≥10N (≥2.3 lbf). | None | The test meets the
Acceptance
Criteria |
| 9. | Seam Strength | Paneffort AAMI Level 3
Isolation Gown,
32 samples each from 3
different lots | ASTM D1683/ D1683M-11a:
Standard Test Method for Failure in Sewn Seams
of Woven Fabrics | ≥30N (≥7 lbf). | None | The test meets the
Acceptance
Criteria |
| 10. | Flammability | Paneffort AAMI Level 3
Isolation Gown
32 samples each from 3
different lots | 16 CFR Part 1610
-2008: Standard for the Flammability of
Clothing Textiles | Class I. Textile
exhibiting normal
flammability. | None | The test meets the
Acceptance
Criteria |
| 11. | Water Vapour
resistance | Paneffort AAMI Level 3
Isolation Gown
32 samples each from 3
different lots | ASTM F1868-17,
Procedure Part B: Standard Test
Method for Thermal and Evaporative
Resistance of Clothing Materials Using a
Sweating Hot Plate | 0,0-1,0 kPa.m2 / W | None | The test meets the
Acceptance
Criteria |
11
12
Traditional 510(k) Paneffort AAMI Level 3 Isolation Gown
7. Biocompatibility Testing
Biocompatibility tests were performed as per the ISO 10993-1:2018 Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process. The In-Vitro cytotoxicity, Skin irritation and Skin sensitization parameters were tested as per the below standards:
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- ISO 10993-5:2009 Biological Evaluation of Medical Device, Part 5-Tests for In Vitro cytotoxicity
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- ISO 10993-10:2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization
The Paneffort AAMI Level 3 Isolation gowns passed biocompatibility studies per ISO-10993
8. Clinical Testing
No clinical study is included in this submission.
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device, the Paneffort AAMI Level 3 Isolation gown, is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K160361).