(106 days)
The Welspun Health Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only.
Welspun Health Surgical Mask is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in two colors – medical blue (Model No.: WHSM002ELB) and white (Model No.: WHSM002ELW). The Welspun Health Surqical Mask is three-layer, flat pleated mask. It is made up of three layers of non-woven polypropylene on automatic mask making machine using the ultrasonic sealing technology. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The ear loops are made of round knitted elastic band. The nose strip contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core aluminium wire. The surgical masks are single-use, disposable devices, provided non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Welspun Health Surgical Mask, formatted as requested:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria (for Level 3 Classification as per ASTM F2100) | Proposed Device Model No.: WHSM002ELB Performance | Proposed Device Model No.: WHSM002ELW Performance | Result |
|---|---|---|---|---|
| Fluid resistance (ASTM F1862/F1862M-17) | 29 out of 32 Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03(2017)) | ≥ 98% | >99% | >99% | Pass |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% | >98% | >98% | Pass |
| Differential pressure (ΔΡ) (EN 14683 (Annex C):2019) | < 6.0 mm H2O/cm² | < 5.0 mm H2O/cm² | < 6.0 mm H2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10:2010) | Non-irritating | Non-irritating | Non-irritating | Pass |
| Sensitization (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing | Non-sensitizing | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific performance test (e.g., number of masks tested for fluid resistance, BFE, PFE). However, for Fluid Resistance, the acceptance criteria are stated as "29 out of 32 Pass at 160 mmHg," which implies a sample size of at least 32 for that particular test.
The data provenance is not explicitly stated as "retrospective" or "prospective." The tests were conducted to demonstrate the effectiveness and safety of the device according to specified standards. Given that this is a 510(k) submission for a new device, these tests would typically be prospective and conducted specifically for this submission. The applicant is Welspun India Limited, based in India, so the testing was likely performed in India or by an accredited lab on behalf of Welspun.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable as the provided document describes performance testing for a surgical mask, not a diagnostic or AI device that relies on expert interpretation for ground truth. The "ground truth" for surgical mask performance is established by standardized, objective laboratory test methods (e.g., measuring filtration efficiency, fluid resistance) against predefined numerical criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is Not Applicable. Adjudication methods like 2+1 or 3+1 consensus are typically used in studies involving subjective human interpretation (e.g., radiology reads) to resolve discrepancies. For the objective laboratory tests conducted on the surgical mask, there is no human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is Not Applicable. The device described is a surgical mask, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is Not Applicable. The device is a physical surgical mask, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by the results of standardized laboratory tests as defined by:
- ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2101-19: Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials
- ASTM F2299/F2299M-03(2017): Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates
- EN 14683 (Annex C):2019: Medical Face Masks - Requirements And Test Methods (for Differential Pressure)
- ASTM F1862/F1862M-17: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood
- 16 CFR 1610: Standard for the Flammability of clothing textiles
- 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
These standards define the methodologies and acceptable performance thresholds that constitute the "ground truth" for the device's claims of safety and effectiveness.
8. The sample size for the training set
This is Not Applicable. The document describes a physical medical device (surgical mask) that does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is Not Applicable for the same reasons as above.
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Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
September 1, 2021
Welspun India Limited % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504
Re: K211536
Trade/Device Name: Welspun Health Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 3, 2021 Received: August 6, 2021
Dear Manoj Zacharias:
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
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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,
For Clarence W. Murray, III, 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
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Indications for Use
510(k) Number (if known) K211536
Device Name Welspun Health Surgical Mask
Indications for Use (Describe)
The Welspun Health Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo features a stylized blue "W" on the left, followed by the words "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" are the words "ADVANCED TEXTILES" in a smaller, gray font.
510(k) Summary (K211536)
[AS REQUIRED BY 21CFR807.92]
APPLICANT INFORMATION I.
| Submitter's Name and Address | Welspun India Limited (Advanced Textiles Division),Survey No. 719, Village: Versamedi, Tal: Anjar,District: Kutch , Gujarat, 370110, India | |
|---|---|---|
| Fax | +91 2836 279010 | |
| Contact person | Mr. Satyapriya Dash | |
| Designation | AGM, Head TQM & PD | |
| Contact Number | +91-7359072111 | |
| Contact E-mail | satyapriya dash@welspun.com, care@welspun.com | |
| Date of Summary Prepared | 03 August 2021 |
II. DEVICE DETAILS
| Device Trade Name | Welspun Health Surgical Mask |
|---|---|
| Device Common Name | Surgical Face Mask |
| Model(s) | WHSM002ELB, WHSM002ELW |
| Device Classification name | Mask, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |
Welspun India Limited
Corporate Office : Welspun House, 7th Floor, Kamala Mills Compound, Senapat Marg, Lower Parel, Mumbai 400 013, India. T: +91 226613600 / 2490 8000 Fax: +91 22 2490 8020
E-mail: nonwovens@welspun.com Website: www.welspun.com
Plant I: Survey No. 76, Village Morai, Vapi, District Valsad, Gujarat 396 191, India. T: +91 260 2437437 Fax: +91 260 2437088
Registered Office & Plant II : Survey No. 719, Village: Varsamedi, Tal : Anjar, District : Kutch , Gujarat - 370110, India. T: +91 2836 661111 Fax: +91 2836 279010
Page 1 of 7
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Image /page/4/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo consists of a blue stylized "W" on the left, followed by the words "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" is the phrase "ADVANCED TEXTILES" in a smaller, gray font.
III. PREDICATE DEVICE DETAILS
| Device Trade Name | Disposable Medical Surgical Mask |
|---|---|
| Device Manufacturer Name | Improve Medical (HuNan) Co., Ltd. |
| 510(k) Number | K202511 |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |
DEVICE DESCRIPTION IV.
Welspun Health Surgical Mask is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in two colors – medical blue (Model No.: WHSM002ELB) and white (Model No.: WHSM002ELW).
The Welspun Health Surqical Mask is three-layer, flat pleated mask. It is made up of three layers of non-woven polypropylene on automatic mask making machine using the ultrasonic sealing technology.
The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The ear loops are made of round knitted elastic band.
The nose strip contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core aluminium wire.
The surgical masks are single-use, disposable devices, provided non-sterile.
V. INDICATIONS FOR USE
The Welspun Health Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only.
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Image /page/5/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo features a blue stylized "W" symbol on the left. To the right of the symbol is the text "WELSPUN INDIA" in bold, black letters, with the words "ADVANCED TEXTILES" in a smaller font size underneath.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI. WITH THE PREDICATE DEVICE
Table 1: General Comparison
| Sl.No | Features compared | Proposed Device | Predicate Device | Result |
|---|---|---|---|---|
| General Information | ||||
| 1. | 510(k) Number | K211536 | K202511 | - |
| 2. | Manufacturer | Welspun India Limited | Improve Medical (HuNan) Co.,Ltd. | - |
| 3. | Common Name | Surgical face mask | Surgical face mask | Same |
| 4. | Classification Name | Mask, Surgical | Mask, Surgical | Same |
| 5. | Classification andRegulation number | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Same |
| 6. | Product Code | FXX | FXX | Same |
| 7. | Indication For Use | The Welspun Health SurgicalMask is intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. The surgical facemasks are intended for use ininfection control practices toreduce the potential exposureto blood & body fluid. Thisdevice is disposable, non-sterile and for single use only. | The Disposable MedicalSurgical Masks are intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Theseface masks are intended foruse in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is a singleuse, disposable device(s),provided non-sterile. | Same |
| 8. | Model specifications | 3 ply flat pleated masks withear loops | Ear loops, Flat Pleated, 3layers | Same |
| Materials | ||||
| 9. | Outer layer | Spun bond polypropylene | Spun bond polypropylene | Same |
| SI.No | Features compared | Proposed Device | Predicate Device | Result |
| 10. | Filter layer | Melt blown polypropylenefilter | Melt blown polypropylene filter | Same |
| 11. | Inner layer | Spun bond polypropylene | Spun bond polypropylene | Same |
| 12. | Nose strip | Polypropylene coated singlecore aluminium wire | Polyethylene coated steel wire | Different(1) |
| 13. | Ear loops | Knitted elastic band | Polyester | Different(2) |
| 14. | Mask style | Flat pleated | Flat pleated | Same |
| 15. | Mask color | Medical Blue, White | Blue | Different(3) |
| 16. | Dimensions | Length- 175 ± 5 mmWidth- 95 ± 5 mmEar Loop Length: 160±10mm | Length-17.5 ± 0.2 cmWidth- 9.5 ± 0.2 cm | Similar |
| 17. | OTC Use | Yes | Yes | Same |
| 18. | Sterility | Non-sterile | Non-sterile | Same |
| 19. | Usage | Single use, disposable | Single use, disposable | Same |
| 20. | ASTM F2100 Level | Level 3 | Level 3 | Same |
| Non Clinical Testing | ||||
| 21. | Fluid resistance | Pass at 160 mmHg | 32 out of 32 pass at 160mmHg | Similar |
| 22. | Flammability | Class I | Class 1 | Same |
| 23. | Particulate FiltrationEfficiency (PFE) | >99% | Pass at 98.6% | Similar |
| 24. | Bacterial FiltrationEfficiency (BFE) | >98% | Pass at 99.9% | Similar |
| 25. | Differential pressure(ΔΡ) | < 6.0 mm H₂0/cm² | Pass at 3.5 mmH₂0/cm² | Similar |
| 26. | BiocompatibilityTesting | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Under the condition of this study the device is non-cytotoxic, non-sensitizing and non-irritating. | Same |
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Image /page/6/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo consists of a blue stylized "W" on the left, followed by the text "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" is the text "ADVANCED TEXTILES" in a smaller, lighter font.
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Image /page/7/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo features a stylized blue "W" symbol on the left. To the right of the symbol is the text "WELSPUN INDIA" in bold, black letters, with the words "ADVANCED TEXTILES" in smaller, gray letters underneath.
VII. JUSTIFICATION FOR DIFFERENCES
The difference is mainly observed in the nose strip, ear loop and color. The differences between proposed device and the predicate device are discussed in detail below and the justification for these are included:
Different(1): The proposed device is using nose strip of polypropylene coated single core aluminium wire whereas the predicate device is using polyethylene coated steel wire.
Different(2): In the proposed device ear loops are made using knitted elastic band not made from natural rubber latex. But, in the predicate device the ear loops are made of polyester.
Different(3): The proposed device is available in two colors - medical blue (Model No.: WHSM002ELB) and white (Model No.: WHSM002ELW) whereas the predicate device is available only in one color- blue.
Justification: Biocompatibility testing in accordance with ISO 10993-1 and performance testing as per ASTM F2100 have been conducted on the final finished device. The proposed device meets the acceptance criteria for level 3 classification as per requirements of performance standard ASTM F2100 and also passes the biocompatibility tests. The safety and effectiveness of Welspun Health Surqical Mask has been demonstrated through the different non-clinical testing performed on these masks. Therefore, the differences between proposed device and the predicate device does not raise any issue regarding the safety or effectiveness of Welspun Health Surgical Mask.
VIII. PERFORMANCE DATA
A. Non- Clinical Data
Performance Tests
Welspun Health Surgical Mask is subjected to the following performance tests according to the requirements provided in the quidance Surgical Masks - Premarket Notification [510(k)] Submissions and is found to be efficient with respect to its intended use:
- . Fluid resistance
- . Bacterial filtration efficiency
- . Particulate filtration efficiency
- . Differential pressure
- . Flammability
The performance testing of the proposed device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant methods cited below:
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Image /page/8/Picture/0 description: The image shows the logo for Welspun India Advanced Textiles. The logo consists of a blue stylized "W" on the left, followed by the text "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" is the text "ADVANCED TEXTILES" in a smaller, gray font.
| ASTM F2100-19 | : | Standard Specification for Performance of Materials Used in Medical FaceMasks |
|---|---|---|
| ASTM F2101-19 | : | Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE)Of Medical Face Mask Materials, Using A Biological Aerosol Of StaphylococcusAureus. |
| ASTM F2299/F2299M -03(2017) | : | Standard Test Method for Determining the Initial Efficiency of Materials Usedin Medical Face Masks to Penetration by Particulates Using Latex Spheres |
| EN 14683 (Annex C):2019 | : | Medical Face Masks - Requirements And Test Methods |
| ASTM F1862/F1862M-17 | : | Standard Test Method for Resistance of Medical Face Masks to Penetrationby Synthetic Blood (Horizontal Projection of Fixed Volume at a KnownVelocity) |
| 16 CFR 1610 | : | Standard for the Flammability of clothing textiles |
The summary of performance testing on the proposed device models WHSM002ELW are given in the table 2 below.
Table 2: Performance Testing Summary
| Sl.No | Test Performed | Proposed Device | Acceptance criteriafor Level 3Classification asper ASTM F2100Requirements | Result | |
|---|---|---|---|---|---|
| Model No. :WHSM002ELB | Model No. :WHSM002ELW | ||||
| 1. | Fluid resistanceASTM F1862/F1862M-17 | Pass at 160mmHg | Pass at 160mmHg | 29 out of 32 Pass at160 mmHg | Pass |
| 2. | Particulate FiltrationEfficiency (PFE)ASTM F2299 / F2299M- 03(2017) | >99% | >99% | ≥ 98% | Pass |
| 3. | Bacterial FiltrationEfficiency (BFE)ASTM F2101-19 | >98% | >98% | ≥ 98% | Pass |
| 4. | Differential pressure(ΔΡ)EN 14683 (Annex C):2019 | < 5.0 mmH2O/cm² | < 6.0 mmH2O/cm² | < 6.0 mm H2O/cm² | Pass |
| 5. | Flammability16 CFR 1610 | Class 1 | Class 1 | Class 1 | Pass |
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Image /page/9/Picture/0 description: The image shows the logo for Welspun India. The logo consists of a blue stylized "W" symbol on the left, followed by the text "WELSPUN INDIA" in bold, black letters. Below "WELSPUN INDIA" is the text "ADVANCED TEXTILES" in a smaller, gray font.
Biocompatibility
The following tests is performed on the Welspun Health Surgical Mask as per requirements in guidance Surgical
Masks - Premarket Notification [510(k)] Submissions and the FDA guidance, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and is found to be safe with respect to its intended use:
- . In vitro Cytotoxicity
- . Skin irritation
- . Skin Sensitization
These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process.
The biocompatibility testing of the proposed device was conducted to adequately demonstrate the safety of the device in accordance with the relevant methods cited below:
- 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.
Table 3: Biocompatibility Test Summary
| SI.No | TestPerformed | Standard | Proposed Device | Result | |
|---|---|---|---|---|---|
| Model No. :WHSM002ELB | Model No. :WHSM002ELW | ||||
| 1. | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Pass |
| 2. | Irritation | ISO 10993-10:2010 | Non-irritating | Non-irritating | Pass |
| 3. | Sensitization | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing | Pass |
B. Clinical Test Data
Clinical study was not conducted as clinical data is not needed for surgical mask.
CONCLUSION IX.
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.