(396 days)
The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The proposed device (model: ZSFM 23) is blue color, four-layer, and flat pleated type mask, utilizing tie-on way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 24) is blue color, three-layer, and flat pleated type mask, utilizing ear loops way for wearing, and it has nose clips design for fitting the face mask around the nose.
The proposed device (model: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The proposed device (model: ZSFM 24) is manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Surgical Mask (Models ZSFM23 and ZSFM24)
Manufacturer: Wuhan Zonsen Medical Products Co., Ltd
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (ZSFM 23 - Level 3) | Reported Performance (ZSFM 23) | Acceptance Criteria (ZSFM 24 - Level 1) | Reported Performance (ZSFM 24) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% | PASS: Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% | ≥95% | PASS: Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% |
| Differential Pressure | < 6.0 mmH₂O/cm² | PASS: Lot 1: 4.86; Lot 2: 4.83; Lot 3: 4.87 (mmH₂O/cm²) | < 5.0 mmH₂O/cm² | PASS: Lot 1: 4.5; Lot 2: 4.5; Lot 3: 4.5 (mmH₂O/cm²) |
| Sub-micron Particulate Filtration Efficiency | ≥98% | PASS: Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9% | ≥95% | PASS: Lot 1: 98.5%; Lot 2: 98.6%; Lot 3: 98.6% |
| Synthetic Blood Penetration | Pass at 160 mm Hg | PASS: Lot 1: 32/32 pass at 160 mm Hg; Lot 2: 32/32 pass at 160 mm Hg; Lot 3: 32/32 pass at 160 mm Hg | Pass at 80 mm Hg | PASS: Lot 1: 32/32 pass at 80 mm Hg; Lot 2: 32/32 pass at 80 mm Hg; Lot 3: 32/32 pass at 80 mm Hg |
| Flammability | Class 1 | PASS: Class 1 | Class 1 | PASS: Class 1 |
| Cytotoxicity | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. |
| Irritation | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. |
| Sensitization | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For performance tests, three non-consecutive lots were tested for each model (ZSFM23 and ZSFM24). Within each lot, a sample size of 32 was used for each performance test (BFE, Differential Pressure, Sub-micron Particulate Filtration Efficiency, Synthetic Blood Penetration, Flammability). For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated as a number of masks, but "the device" was evaluated.
- Data Provenance: Not specified in the provided text (e.g., country of origin for the testing facilities, specific dates). The study appears to be a prospective evaluation of newly manufactured devices/lots, rather than a retrospective analysis of existing data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This device (Surgical Mask) involves performance testing against established industry standards and biological evaluations, not diagnostic interpretation by human experts. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense does not apply here. The "ground truth" is defined by the objective pass/fail criteria of the specified ASTM, EN, and ISO standards.
4. Adjudication Method
- Again, this is not applicable for performance testing of a physical medical device like a surgical mask. Results are determined by standardized laboratory methods and measurements, not by human expert adjudication of subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human interpretation (e.g., in radiology). The submitted device is a physical product (surgical mask) whose performance is evaluated against material standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm or software device. The "standalone performance" is the direct physical and biological performance of the surgical mask itself, as measured by the specified tests.
7. The Type of Ground Truth Used
- The "ground truth" for the acceptance criteria and evaluation is derived from established international standards and regulatory guidance for medical face masks. Specifically:
- ASTM F2100-20 (Standard Specification for Performance of Materials Used In Medical Face Masks)
- ASTM F1862-17 (Resistance of Medical Face Masks To Penetration by Synthetic Blood)
- EN 14683:2019 (Requirements and Test Methods of Differential Pressure of Medical Face Mask)
- ASTM F2101-19 (Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials)
- ASTM F2299-17 (Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates)
- 16 CFR Part 1610-2008 (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)
- The "ground truth" is therefore objective, measurable, and defined by these recognized scientific and regulatory benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set. The masks are physical products subject to direct performance testing.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
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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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 16, 2022
Wuhan Zonsen Medical Products Co., Ltd Cynthia Ye General Manager No 8 Jinchao Road, Zhucheng Street, Xinzhou District Wuhan, Hubei 431000 China
Re: K213601
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 11, 2022 Received: November 21, 2022
Dear Ms. Ye:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K213601
Device Name Surgical Mask
Indications for Use (Describe)
The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
510k Number: K213601 Revised date: May 12, 2022
A. Applicant:
Wuhan Zonsen Medical Products Co., Ltd Address: No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan, Hubei, China Contact Person: Cynthia Ye Tel: +86- 27-82737771
Submission Correspondent: Primary contact: Cynthia Ye Tel: +86-27-82737771 Email: Cynthia@zonsenmed.com Secondary contact: Linna Ye Tel: +86-27-82737772 Email: registration01@zonsenmed.com
B. Device:
Trade Name: Surgical Mask Common Name: Surgical Mask Model(s): ZSFM23, ZSFM24
Regulatory Information Classification Name: Surgical Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K211827 Level 3 Fluid Resistant Procedure/Surgical Mask Zhejiang Lanhine Medical Products LTD.
D. Indications for use :
The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
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Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan, Hubei, China
The proposed device (model: ZSFM 23) is blue color, four-layer, and flat pleated type mask, utilizing tie-on way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 24) is blue color, three-layer, and flat pleated type mask, utilizing ear loops way for wearing, and it has nose clips design for fitting the face mask around the nose.
The proposed device (model: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The proposed device (model: ZSFM 24) is manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
| ComparisonComponent | Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Manufacturer | Wuhan Zonsen Medical ProductsCo., Ltd | Zhejiang Lanhine MedicalProducts LTD. | / | |
| 510K number | K213601 | K211827 | / | |
| Device name | Surgical Mask | Level 3 Fluid ResistantProcedure/Surgical Mask | / | |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same | |
| ComparisonComponent | Proposed Device | Predicate Device | Comparison | |
| Indications for use | The Surgical Masks (model:ZSFM 23, ZSFM 24) are intendedto be worn to protect both thepatient and healthcare personnelfrom transfer of microorganisms,body fluids and particulatematerial. These masks areintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device(s), providednon-sterile. | The Level 3 FluidResistant Procedure/SurgicalMask (model: 15604F, 15704F)are intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This a singleuse, disposable device(s),provided non-sterile. | Same | |
| Ear loop model andtie-on model | Model: ZSFM 23, Tie-On, FlatPleated, 4 layersModel: ZSFM 24, Ear Loops, FlatPleated, 3 layers | Ear Loops, Tie-On, FlatPleated, 3 layers | Similar | |
| Same | ||||
| Outerlayer | Polypropylene non-woven fabric | Non-woven Fabric(Polypropylene) | Same | |
| Middlelayer(s) | Polypropylene Melt blownnon-woven fabric | Melton brown Fabric(Polypropylene) | Same | |
| Material | Innerlayer | Polypropylene non-woven fabric | Non-woven Fabric(Polypropylene) | Same |
| Nose clip | Malleable polyethylene | Polypropylene coatingiron | Similar | |
| Tie-onbands | Polypropylene non-woven fabric | Non-woven Fabric(Polypropylene) | Same | |
| Ear loops | Spandex | Polyurethane | Same | |
| Color | Blue | Blue | Same | |
| Dimension | 17.5 cm +/- 0.5 cm | 17.5 cm +/- 0.5 cm | Same | |
| 9.5 cm +/- 0.5 cm | 9.5 cm +/- 0.5 cm | Same | ||
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single use; disposable | Single use; disposable | Same | |
| ASTM F2100 Level | Model: ZSFM 23, Level 3 | Level 3 | Same | |
| ComparisonComponent | Proposed Device | Predicate Device | Comparison | |
| Model: ZSFM 24, Level 1 | Similar | |||
| Biocompatibility | Meet ISO10993-5and ISO10993-10 | ISO10993 | Same |
F. Comparison with predicate device
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Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan, Hubei, China
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G. Summary of Non-Clinical Test
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff. Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity:
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization:
- A ASTM F2100-20, Standard Specification for Performance of Materials Used In Medical Face Masks:
-
ASTM F1862-17, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood;
-
EN 14683: 2019, Requirements and Test Methods of Differential pressure of Medical Face Mask:
-
ASTM F2101-19, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299-17, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
| Test results of Proposed device | |||||
|---|---|---|---|---|---|
| Performance | Purpose | Requirement | Surgical Mask(model: ZSFM 23) | Surgical Mask(model: ZSFM 24) | |
| BacterialFiltrationEfficiencyASTMF2101-19 | Assess theperformance ofa mask topenetration by aprepared solutionwith knownconcentration of anindicator bacterialorganism | Level 1: ≥95%Level 3: ≥98% | PASS3 non-consecutive lotstested, using a samplesize of 32/ lot.Lot 1: 99.9%;Lot 2: 99.9%;Lot 3: 99.9%; | PASS3 non-consecutive lotstested, using a samplesize of 32/ lot.Lot 1: 99.9%;Lot 2: 99.9%;Lot 3: 99.9%; | |
| DifferentialPressure | Assess theperformance of | Level 1:<5.0mmH2O/cm² | PASS3 non-consecutive lots | PASS3 non-consecutive lots |
Table 2 - Performance Testing
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Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan, Hubei, China
| EN 14683:2019,Annex C | a mask forresistance toair movementthrough thematerials of the faceof the mask | Level 3:<6.0mmH2O/cm² | tested, using a samplesize of 32/ lot.Lot 1: 4.86;Lot 2: 4.83;Lot 3: 4.87; | tested, using a samplesize of 32/ lot.Lot 1: 4.5;Lot 2: 4.5;Lot 3: 4.5; |
|---|---|---|---|---|
| Sub-micronparticulatefiltrationefficiencyASTMF2299-17 | Assess theperformance ofa mask topenetration bysub-micronpolystyrene latexparticles of 0.1micron | Level 1: ≥95%Level 3: ≥98% | PASS3 non-consecutive lotstested, using a samplesize of 32/ lot.Lot 1: 99.9%;Lot 2: 99.9%;Lot 3: 99.9%; | PASS3 non-consecutive lotstested, using a samplesize of 32/ lot.Lot 1: 98.5%;Lot 2: 98.6%;Lot 3: 98.6%; |
| Synthetic BloodPenetrationASTMF1862-17 | Assess theperformanceof a mask toresistance to asynthetic bloodpreparation targetedtoward the mask ata set pressure | Level 1: 80 mm HgLevel 3: 160 mm Hg | PASS3 non-consecutive lotstested, using a samplesize of 32/ lot.Lot 1: 32 out of 32pass at 160 mm Hg;Lot 2: 32 out of 32pass at 160 mm Hg;Lot 3: 32 out of 32pass at 160 mm Hg; | PASS3 non-consecutive lotstested, using a samplesize of 32/ lot.Lot 1: 32 out of 32 passat 80 mm Hg;Lot 2: 32 out of 32 passat 80 mm Hg;Lot 3: 32out of 32 passat 80 mm Hg; |
| FlammabilityTest 16 CFRPart 1610-2008 | Assess theresistance of a maskto ignition | Class 1 | PASS3 non-consecutive lotstested, using a samplesize of 32/ lot.Class 1 | PASS3 non-consecutive lotstested, using a samplesize of 32/ lot.Class 1 |
| Conclusion | / | / | Meet the requirementfor Level 3 barrier | Meet the requirementfor Level 1 barrier |
Table 3 -Biological Specifications:
| Performance | Requirement | Results (ZSFM23 & ZSFM24) |
|---|---|---|
| CytotoxicityEN ISO10993-5 | Non-Cytotoxic | PASSUnder the conditions of the study, the device isnon-cytotoxic. |
| IrritationEN ISO 10993-10 | Non-Irritating | PASSUnder the conditions of the study, the device isnon-irritating. |
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| SensitizationEN ISO 10993-10 | Non-Sensitizing | PASSUnder the conditions of the study, the device isnon-sensitizing. |
|---|---|---|
| ---------------------------------- | ----------------- | ------------------------------------------------------------------------------ |
H. Clinical Performance
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission, the Surgical Mask (model: ZSFM23, ZSFM24), is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K211827.
§ 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.