(181 days)
The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Surgical Mask, is a single use, three-layer, flat-pleated mask. The inner and outer layers of the mask are made of PP Spunbonded Non-woven Fabric, and the middle layer is made of Melt-blown Nonwoven Fabric. The proposed devices are available in three types, ear-loop, Tie-on and Headband. The ear straps of headband type and ear loop type are made of Spandex and Polyester, and the ear strap of tie-on type is made of PP Spunbonded Non-woven Fabric. The ear strap is held in place over the users' mouth and nose. The nose clip is made of Galvanized Iron Wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops, tie-on and headband masks are available in different sizes to provide more options for user, as shown in the following table. The proposed devices were available with and without edging and they can be provided in sterile and non-sterile two versions. The proposed devices are blue.
The provided text is a 510(k) Summary for a Surgical Mask (K210908). This document describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML-based medical device.
Therefore, the information requested in your prompt regarding acceptance criteria and study proving an AI/ML device meets them (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.
The document focuses on the physical and biological performance characteristics of the surgical masks. Here's a breakdown of the relevant information provided in relation to performance, but specifically for a surgical mask, not an AI device:
1. Table of acceptance criteria and reported device performance (for the Surgical Mask):
| Test | Acceptance Criteria | Reported Device Performance (Surgical Mask) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Viability $\geq$ 70% of blank | Viability of tested samples (PRS-WK002, PRS-WK017) $\geq$ 70% of the blank. 50% extract had higher viability than 100% extract. (Non-cytotoxic) |
| Sensitization | Non-sensitizing | No evidence of causing delayed dermal contact sensitization in guinea pigs for tested samples (PRS-WK002, PRS-WK017). (Non-sensitizing) |
| Irritation | Non-irritating | Irritation response category for tested samples (PRS-WK002, PRS-WK017) was Negligible for polar and non-polar extracts. (Non-irritating) |
| Performance Testing | ||
| Resistance to Penetration by Synthetic Blood (at 120 mmHg) | No penetration at 120 mmHg | Sterile Ear loop Non-edging (PRS-WK002): Pass at 120mmHg for 3 lots. Non-sterile Ear loop Non-edging (PRS-WK017): Pass at 120mmHg for 3 lots. |
| Particulate Filtration Efficiency (PFE) | $\geq$98% | Sterile Ear loop Non-edging (PRS-WK002): 98.19%, 98.20%, 98.24% for 3 lots (Average 98.21%). Non-sterile Ear loop Non-edging (PRS-WK017): 98.22%, 98.16%, 98.22% for 3 lots (Average 98.20%). |
| Bacterial Filtration Efficiency (BFE) | $\geq$98% | Sterile: Average 99.64%. Non-sterile: Average 99.60%. Individual lot results provided were all >99.5%. |
| Differential Pressure | <6.0 $mmH_2O/cm^2$ | Sterile Ear loop Non-edging (PRS-WK002): 3.03, 3.01, 3.01 $mmH_2O/cm^2$ for 3 lots (Average 3.02 $mmH_2O/cm^2$). Non-sterile Ear loop Non-edging (PRS-WK017): 2.88, 2.88, 2.85 $mmH_2O/cm^2$ for 3 lots (Average 2.87 $mmH_2O/cm^2$). |
| Flammability | Class 1 | All tested models/lots (Sterile Ear loop Edging, Non-edging; Headband Edging, Non-edging; Tie-on; Non-sterile Ear loop Edging, Non-edging; Headband Edging, Non-edging; Tie-on) showed Class 1 results. |
Regarding the specific questions about an AI/ML device:
- 2. Sample sized used for the test set and the data provenance: Not applicable to a surgical mask. Tests were performed on samples of the mask.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance tests were laboratory-based, not expert-opinion based.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the surgical mask's performance is objective measurement against established standards (e.g., ASTM, EN, ISO).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
In conclusion, the provided document is a 510(k) submission for a physical medical device (surgical mask) and does not contain the type of information requested for a software AI/ML device. The "study that proves the device meets the acceptance criteria" refers to the non-clinical laboratory tests detailed in the document, which demonstrate the mask's physical and biological barrier properties meet the relevant standards for its intended use.
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 26, 2021
Sichuan Prius Biotechnology Co., Ltd. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, 200120 China
Re: K210908
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 9, 2021 Received: August 17, 2021
Dear Diana Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Surgical Mask (Model numbers identified in the attachment)
Indications for Use (Describe)
The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
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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| Model | Size (cm) | Ear loop | Headband | Tie-on | Sterile | Non-sterile | Non-edging type | Edging type |
|---|---|---|---|---|---|---|---|---|
| PRS-WK001 | 17.5×9.5 | √ | √ | √ | ||||
| PRS-WK002 | 17.5×9.5 | √ | √ | √ | ||||
| PRS-WK003 | 17.5×9.5 | √ | √ | √ | ||||
| PRS-WK004 | 17.5×9.5 | √ | √ | √ | ||||
| PRS-WK005 | 17.5×9.5 | √ | √ | NA | ||||
| PRS-WK006 | 14.5×9.5 | √ | √ | √ | ||||
| PRS-WK007 | 14.5×9.5 | √ | √ | √ | ||||
| PRS-WK008 | 14.5×9.5 | √ | √ | √ | ||||
| PRS-WK009 | 14.5×9.5 | √ | √ | √ | ||||
| PRS-WK010 | 14.5×9.5 | √ | √ | NA | ||||
| PRS-WK016 | 17.5×9.5 | √ | √ | √ | ||||
| PRS-WK017 | 17.5×9.5 | √ | √ | √ | ||||
| PRS-WK018 | 17.5×9.5 | √ | √ | √ | ||||
| PRS-WK019 | 17.5×9.5 | √ | √ | √ | ||||
| PRS-WK020 | 17.5×9.5 | √ | √ | NA | ||||
| PRS-WK021 | 14.5×9.5 | √ | √ | √ | ||||
| PRS-WK022 | 14.5×9.5 | √ | √ | √ | ||||
| PRS-WK023 | 14.5×9.5 | √ | √ | √ | ||||
| PRS-WK024 | 14.5×9.5 | √ | √ | √ | ||||
| PRS-WK025 | 14.5×9.5 | √ | √ | NA |
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K210908
-
- Date of Preparation: 09/14/2021
-
- Sponsor Identification
Sichuan Prius Biotechnology Co., Ltd.
No. 2, Prius Road, Luo Long Industrial Park Nanxi District, 644104 Yibin City, Sichuan Province, PEOPLE'S REPUBLIC OF CHINA.
Establishment Registration Number: Not registered yet.
Contact Person: Yan Liu Position: management representative Tel: +86-831-3839889 Fax: +86-831-3839887 Email: 48363603@qq.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
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- Identification of Proposed Device 4.
Product Name: Surgical Mask Common Name: Surgical Masks
Regulatory Information Classification Number: 21 CFR 878.4040 Classification Name: Surgical apparel Product Code: FXX Regulatory Class: II Review Panel: General Hospital
-
- Identification of Predicate Device
510(k) Number: K202843 Product Name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) Sponsor Name: B.J.ZH.F. Panther Medical Equipment Co., Ltd. Whether subject to a design-related recall: No
- Identification of Predicate Device
6. Device Description:
The proposed device, Surgical Mask, is a single use, three-layer, flat-pleated mask. The inner and outer layers of the mask are made of PP Spunbonded Non-woven Fabric, and the middle layer is made of Melt-blown Nonwoven Fabric. The proposed devices are available in three types, ear-loop, Tie-on and Headband. The ear straps of headband type and ear loop type are made of Spandex and Polyester, and the ear strap of tie-on type is made of PP Spunbonded Non-woven Fabric. The ear strap is held in place over the users' mouth and nose. The nose clip is made of Galvanized Iron Wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops, tie-on and headband masks are available in different sizes to provide more options for user, as shown in the following table. The proposed devices were available with and without edging and they can be provided in sterile and non-sterile two versions. The proposed devices are blue.
| Model | Sterile | Non-sterile | Earloop | Tie-on | Headband | Size(cm) | Non-edgingtype | Edgingtype | Color |
|---|---|---|---|---|---|---|---|---|---|
| PRS-WK002 | √ | √ | 17.5×9.5 | √ | Blue | ||||
| PRS-WK003 | √ | √ | 17.5×9.5 | √ | Blue | ||||
| PRS-WK004 | √ | √ | 17.5×9.5 | √ | Blue | ||||
| PRS-WK005 | √ | √ | 17.5×9.5 | NA | Blue |
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| PRS-WK006 | √ | √ | 14.5×9.5 | √ | Blue |
|---|---|---|---|---|---|
| PRS-WK007 | √ | 14.5×9.5 | √ | Blue | |
| PRS-WK008 | √ | 14.5×9.5 | √ | Blue | |
| PRS-WK009 | √ | 14.5×9.5 | √ | Blue | |
| PRS-WK010 | √ | 14.5×9.5 | NA | Blue | |
| PRS-WK016 | √ | 17.5×9.5 | √ | Blue | |
| PRS-WK017 | √ | 17.5×9.5 | √ | Blue | |
| PRS-WK018 | √ | 17.5×9.5 | √ | Blue | |
| PRS-WK019 | √ | 17.5×9.5 | √ | Blue | |
| PRS-WK020 | √ | 17.5×9.5 | NA | Blue | |
| PRS-WK021 | √ | 14.5×9.5 | √ | Blue | |
| PRS-WK022 | √ | 14.5×9.5 | √ | Blue | |
| PRS-WK023 | √ | 14.5×9.5 | √ | Blue | |
| PRS-WK024 | √ | 14.5×9.5 | √ | Blue | |
| PRS-WK025 | √ | 14.5×9.5 | NA | Blue |
7. Indications for Use:
The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
-
- Summary of Technological characteristics
| ITEM | Proposed Device | Predicate Device K202843 | Remark |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. | The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. | Same |
| Mask style | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Same |
| Color | Blue | Blue | Same |
| Dimension | |||
| 17.5cm×9.5cm14.5cm×9.5cm | 17.5cm×9.5cm14.5cm×9cm | Same | |
| Level | Level 2 | Level 2 | Same |
| Sterility | Sterile/Non-Sterile | Sterile/Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Fluid resistance | Sterile: Pass at 120mmHgNon-sterile: Pass at 120mmHg | Pass at 120mmHg | Same |
| Particulate Filtration Efficiency | Sterile: Average 98.21%Non-sterile: Average 98.20% | Average 98.98% | Different |
| Bacterial Filtration Efficiency | Sterile: Average 99.64%Non-sterile: Average 99.60% | Average 98.92% | Different |
| Differential Pressure | Sterile: Average 3.02 mmH2O/cm²Non-sterile: Average 2.87 mmH2O/cm² | Average 4.4 mmH2O/cm² | Different |
| Flammability | Class 1 | Class 1 | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Patient Contacting Material | |||
| Outer layer of mask | PP Spunbonded Non-woven Fabric | Spun-bonded nonwoven polypropylene | |
| Middle layer of mask | Melt-blown Nonwoven Fabric | Melt-blown non-woven polypropylene | |
| Inner layer of mask | PP Spunbonded Non-woven Fabric | Spun-bonded nonwoven polypropylene | Different |
| Nose Clip | Galvanized Iron Wire | Medical polypropylene and Q235 | |
| Ear Strap | PP Spunbonded Non-woven Fabric; Spandex and Polyester | Spun-bonded nonwoven polypropylene; Spandex and nylon | |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5 and ISO 10993-10;Under the conditions of the study, the | ISO 10993-5 and ISO 10993-10;Under the conditions of the study, | |
| Sensitization | proposed device extract was determined to be non-cytotoxic, | the proposed device extract was determined to be non-cytotoxic, | same |
| Irritation | non-sensitizing, and non-irritating. | non-sensitizing, and non-irritating. | |
| Test Method | Purpose | Acceptance Criteria | Results |
| Cytotoxicity | The test was performed in accordance with ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity to evaluate the cytotoxicity of the test sample. | The viability should be $\geq$ 70% of the blank. And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract. | The viability of the tested samples included PRS-WK002 and PRS-WK017 was $\geq$ 70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract.Under the conditions of the study, the proposed device was non-cytotoxic. |
| Sensitization | The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization to evaluate the sensitization of the test | Non-sensitizing | The tested samples included PRS-WK002 and PRS-WK017 showed no evidence of causing delayed dermal contact sensitization in the guinea pigs.Under the conditions of the study, the proposed device was non-sensitizing. |
Table 1 Comparison of Surgical Mask
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Differences in technological characteristics do not raise different questions of safety and effectiveness.
9. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications. The
{8}------------------------------------------------
test results demonstrated that the proposed device complies with the following standards:
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
-
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
-
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
-
EN 14683: 2019 Medical face masks- Requirements and test methods
- A 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: Tests for irritaion and skin sensitization
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
-
ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide Sterilization Residuals
Table 2 Biocompatibility Testing
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| sample. | |||
|---|---|---|---|
| Irritation | The test was performed inaccordance with ISO10993-10 Third Edition2010-08-01 Biologicalevaluation of medicaldevices - Part 10: Tests forirritation and skinsensitization to evaluate theirritation of the test sample. | Non-irritating | The irritation response category ofthe test samples includedPRS-WK002 and PRS-WK017 wasclassified as Negligible for polarextract and Negligible for non-polarextract.Under the conditions of the study,the proposed device wasnon-irritating. |
| Table 3 Performance Testing | |
|---|---|
| ----------------------------- | -- |
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Resistance toPenetration bySyntheticblood | The test was performed inaccordance with ASTMF1862/F1862M:2017Standard Test Method forResistance of Medical FaceMasks to Penetration bySynthetic Blood (HorizontalProjection of Fixed Volumeat a Known Velocity) toevaluate the effectiveness ofthe test sample from possibleexposure to blood and otherbody fluids. | No penetration at 120mmHg | Sterile Ear loop Non-edging(PRS-WK002):Lot 200401: Pass at 120mmHgLot 200407: Pass at 120mmHgLot 200413: Pass at 120mmHgNon-sterile Ear loop Non-edging(PRS-WK017):Lot 200401: Pass at 120mmHgLot 200405: Pass at 120mmHgLot 200407: Pass at 120mmHg |
| ParticulateFiltrationEfficiency | The test was performed inaccordance with ASTMF2299/F2299M-03(2017)Standard Test Method forDetermining the InitialEfficiency of Material Usedin medical Face Masks toPenetration by Particulatesusing Latex Spheres todetermine the particlefiltration efficiency (PFE) ofthe test article. | ≥98% | Sterile Ear loop Non-edging(PRS-WK002):Lot 200401: 98.19%Lot 200407: 98.20%Lot 200413: 98.24%Non-sterile Ear loop Non-edging(PRS-WK017):Lot 200401: 98.22%Lot 200405: 98.16%Lot 200407: 98.22% |
| Bacterial | The test was performed in | ≥98% | Sterile: Average 99.64% |
| Filtration Efficiency | accordance with ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus to determine the bacterial filtration efficiency (BFE) of the test article. | Non-sterile: Average 99.60%Sterile Ear loop Non-edging (PRS-WK002):Lot 210405: 99.74%Lot 210407: 99.72%Lot 210409: 99.70%Non-sterile Ear loop Non-edging (PRS-WK017):Lot 210405: 99.56%Lot 210407: 99.54%Lot 210409: 99.53% | |
| Differential Pressure | The test was performed in accordance with EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods. | <6.0 $mmH_2O/cm^2$ | Sterile Ear loop Non-edging (PRS-WK002):Lot 200401: 3.03 $mmH_2O/cm^2$Lot 200407: 3.01 $mmH_2O/cm^2$Lot 200413: 3.01 $mmH_2O/cm^2$Non-sterile Ear loop Non-edging (PRS-WK017):Lot 200401: 2.88 $mmH_2O/cm^2$Lot 200405: 2.88 $mmH_2O/cm^2$Lot 200407: 2.85 $mmH_2O/cm^2$ |
| Flammability | The test was performed in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles. | Class 1 | Sterile Ear loop Edging (PRS-WK001):Lot 210522: Class 1Lot 210706: Class 1Lot 210812: Class 1Sterile Ear loop Non-edging (PRS-WK002):Lot 200401: Class 1Lot 200407: Class 1Lot 200413: Class 1Sterile Headband Edging (PRS-WK003):Lot 210522: Class 1Lot 210706: Class 1Lot 210812: Class 1 |
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| Sterile Headband Non-edging(PRS-WK004):Lot 210522: Class 1Lot 210706: Class 1Lot 210812: Class 1Sterile Tie-on (PRS-WK005):Lot 210522: Class 1Lot 210706: Class 1Lot 210812: Class 1Non-sterile Ear loop Edging(PRS-WK016):Lot 210817: Class 1Lot 210819: Class 1Lot 210823: Class 1Non-sterile Ear loop Non-edging(PRS-WK017):Lot 200401: Class 1Lot 200405: Class 1Lot 200407: Class 1Non-sterile Headband Edging(PRS-WK018):Lot 210817: Class 1Lot 210819: Class 1Lot 210823: Class 1Non-sterile Headband Non-edging(PRS-WK019):Lot 210817: Class 1Lot 210819: Class 1Lot 210823: Class 1Non-sterile Tie-on (PRS-WK020):Lot 210817: Class 1Lot 210819: Class 1Lot 210823: Class 1 | |
|---|---|
| -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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10. Clinical Test Conclusion
No clinical study is included in this submission.
-
- Conclusion
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202843.
- Conclusion
§ 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.