(367 days)
ALLURETM Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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.
ALLURE™ Surgical mask is valve less, consisting of 5 layers made up of breathable PP non-woven, hot air insulation cotton, two layers of melt blown fabrics, non-woven fabrics and plastic nose strips and Elastic cord. The device is designed and tested as per its device specific guidance; "Surgical Masks-Premarket Notification 510(k) Submissions".
The provided text describes the performance testing for the ALLURE™ Surgical Mask to demonstrate its substantial equivalence to a predicate device. This is not for an AI/ML powered device, therefore no AI-specific information like training data, expert consensus, or MRMC studies are present. The information pertains to the physical performance of the surgical mask based on established ASTM and ISO standards for medical face masks.
Here's an analysis of the provided information within the context of the requested questions, highlighting what is present and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing/Standards | Purpose of the Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862/F1862M-17 Resistance of Medical Face Mask to Penetration by Synthetic blood | To determine the splash resistance/Fluid Penetration- Resistance to blood | Allure Surgical mask should be resistant to Penetration by Synthetic blood | Pass. Allure face mask is resistant to Penetration by Synthetic blood |
| ASTM F2101-19 EN 14683: 2014 Bacterial Filtration Efficiency | To determine the filtration efficiency of Allure Surgical mask by comparing the bacterial control counts upstream of the Allure Surgical Mask to the bacterial counts downstream | Bacterial Filtration Efficiency should be >95.0% | Pass. Filtration Efficiency was found to be >95.0% |
| ASTM F2101-19 EN 14683: 2014 Determination of Breathability | To determine the Breathability test (Differential Pressure Pa.) | Level 1 <5mmH2O/cm² Level 2 <6mmH2O/cm² Level 3 <6mmH2O/cm² | Pass. Allure Face mask meets the requirement for Level 1. |
| 16 CFR Part 1610 Flammability | To determine the flammability as per 16 CFR Part 1610 | Allure Surgical mask shall meet the as per requirements of Class 1 Normal flammability | Pass. Allure face mask is found to be of Class 1: Normal flammability |
| ASTM F2299 / F2299M - 03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | To evaluate the non-viable particle filtration efficiency (PFE) of the Allure Surgical Mask. | Particle Filtration Efficiency Test at 0.1 micron (%) should be >95% | Pass. Allure face mask meets the requirement for Level 1 >95 |
| Biocompatibility | Testing/Standards | Result |
|---|---|---|
| Test for in vitro cytotoxicity: Elution method. | ISO 10993-5:2009(E) | Non-cytotoxic to Balb/c 3T3 cells. |
| Skin Sensitization Test in Guinea Pigs. (Guinea Pig Maximization Test) | ISO 10993-10:2010(E) | Non-sensitizer to Guinea Pigs. |
| Skin Irritation Test in New Zealand White Rabbits. | ISO 10993-10:2010(E) | Non-irritant to New Zealand White Rabbits. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "three non-consecutive lots" were used for performance testing. Specific numerical sample sizes for each test within these lots are not provided.
- Data Provenance: The document does not explicitly state the country of origin where the testing was performed, nor does it specify if the data was retrospective or prospective. It is implied that the testing was performed to meet international standards (ASTM, ISO, EN, CFR), suggesting generalized lab testing rather than clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is a physical product (surgical mask) and its performance is evaluated against material and barrier properties standards, not by expert interpretation of images or data. Therefore, there's no "ground truth" in the clinical sense established by human experts for a test set.
4. Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, performance is measured against objective material standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. MRMC studies are relevant for evaluating diagnostic tools where human readers are involved. This is a physical product, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is a physical surgical mask, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is defined by the acceptance criteria specified in the referenced ASTM, ISO, and CFR standards for surgical masks. These standards define the physical and biological characteristics (e.g., filtration efficiency, fluid resistance, flammability, biocompatibility) that the mask must meet. The tests performed directly measure these properties.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical product, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As no AI/ML model is involved, there is no training set or associated ground truth establishment.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 16, 2022
Allure Gift Wraps Private Limited % Sharad Raisinghani US Agent Allure Life Sciences LLC 4Hancock CT, Basking Ridge, New Jersey, New Jersey 07920
Re: K212926
Trade/Device Name: Allure™ Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 15, 2022 Received: August 25, 2022
Dear Sharad Raisinghani:
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,
Clarence W. Murray, III, PhD 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) K212926
Device Name ALLURETM Surgical Mask
Indications for Use (Describe)
ALLURETM Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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) | |
| 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 Allure Gift Wraps Pvt Ltd. The logo features a green bow on the left side and the word "ALLURE" in colorful blocks above the words "Gift Wraps". The company name, "ALLURE GIFT WRAPS PVT LTD", is printed in red below the logo.
510 (k) Summary-K212926
Device Name- ALLURE™ Surgical Mask
Submission Sponsor Information [21 CFR 807.929(a) (1)] 5.1
Allure Gift Wraps Pvt Ltd Plot No. J 21, J type area, 1st Phase GIDC Vapi, 396195 Vapi, India Cell Phone Number: 91-9819837267 E-mail: sharad@allurewraps.com Website: https://allurewraps.com Primary Contact: Mr Mohan Raisinghani Secondary Contact: Mr Sharad Raisinghani
Date Prepared 5.2
15th September 2022
5.3 Device Identification [21 CFR 807.92(a) (2)|
| Trade/Proprietary Name: | ALLURE™ Surgical Mask |
|---|---|
| Classification Name: | Mask, Surgical |
| Regulation Name: | Surgical apparel |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FXX |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
5.4 Legally marketed device(s) to which equivalence is claimed [21 CFR 807.92(a) (3)|
Surgical Face Mask, Ear Loops, Model 101B, 101G, 136B, 136G, 137B, 137G, Surgical Face Mask, Tie-on, Model 145B, 145G, 143G, 138G, 138G, 142B, 142G, 151B, 151G by KCI USA Inc. by BH Medical Products Co., Ltd. (K133070)
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Image /page/4/Picture/0 description: The image shows the logo for Allure Gift Wraps Pvt Ltd. The logo features a green bow on the left side and the word "ALLURE" in colorful blocks on the right side. Below the word "ALLURE" is the phrase "Gift Wraps" in a cursive font. The words "ALLURE GIFT WRAPS PVT LTD" are printed in red below the logo.
Device Description [21 CFR 807.92(a) (4)] ર્ રંડ
ALLURE™ Surgical mask is valve less, consisting of 5 layers made up of breathable PP nonwoven, hot air insulation cotton, two layers of melt blown fabrics, non-woven fabrics and plastic nose strips and Elastic cord. The device is designed and tested as per its device specific guidance; "Surgical Masks-Premarket Notification 510(k) Submissions".
Image /page/4/Picture/4 description: The image shows a white face mask. The mask is folded and has the word "ALLURE" printed on the front. The mask also has white elastic ear loops.
Figure 5.1: ALLURE™ Surgical Mask (Flat type Mask)
Duration and type of contact: Direct contact, less than 24 hours, skin contact Single use disposable device: Yes Sterile: No
Size of Mask: Dimension (length): 155 ± 5 mm
Dimension (width): 105 ± 5 mm
User Profile/Population: Adults
ASTM Level: ASTM Level 1
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Image /page/5/Picture/0 description: The image shows the logo for Allure Gift Wraps Pvt Ltd. The logo includes a green bow on the left side and the word "ALLURE" in colorful block letters above the words "Gift Wraps" in cursive. Below the logo is the text "ALLURE GIFT WRAPS PVT LTD" in red font.
Use Environment: In a hospital or clinic environment, Operating room.
Image /page/5/Figure/3 description: The image is a technical drawing of a face mask with various dimensions and angles labeled. The height of the mask is 51 units on one side and 124.5 units on the other, with a width of 116 units at the bottom. The angles are labeled as 145 degrees and 131 degrees, and other dimensions include 78 units, 63 units, and 50 units.
NOTE: The scale reading in drawing is in millimeters (mm)
Figure 5.2: ALLURE™ Surgical Mask- ENGINEERING DRAWING
Indications for Use [21 CFR 807.92(a) (5)] 5.6
ALLURE™ surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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.
Comparison of the technological characteristics with the predicate device [21 CFR 5.7 807.92(a) (6)]
The comparison chart below provides evidence to facilitate the substantial equivalence determination between ALLURE™ Surgical Mask and the predicate device (K133070) with respect to the intended use, technological characteristics and principles of operation.
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Image /page/6/Picture/0 description: The image is a logo for Allure Gift Wraps Pvt Ltd. The logo features the word "ALLURE" in colorful blocks above the words "Gift Wraps" in a cursive font. Above the words is a green bow and a light green horizontal line, all contained within a red-lined box.
| Comparisonparameters | ALLURETM Surgical Maskby Allure Gift Wraps PvtLtd | Surgical Face Mask, Ear Loops (Model 101B,101G, 136B, 136G, 137B, 137G) and SurgicalFace Mask, Tie-on (Model 145B, 145G, 143B,143G, 138B, 138G, 142B, 142G) | Comparison |
|---|---|---|---|
| 510(k) Number | K212926 | K133070 | Different |
| Manufacturer | Allure Gift Wraps Pvt Ltd | BH Medical Products Co., Ltd. | Different |
| Proprietary Name | ALLURETM Surgical Mask | Surgical Face Mask, Ear Loops, (Model 101B,101G, 136B, 136G, 137B, 137G) and SurgicalFace Mask, Tie-on, (Model 145B, 145G, 143B,143G, 138B, 138G, 142B, 142G, 151B, 151G) | Different |
| Indications for Use | ALLURETMsurgical masksare intended to be worn toprotect both the patient andhealthcarepersonnelfromtransfer ofmicroorganisms,body fluids and particulatematerial. These face masks areintended for use in infectioncontrol practices to reduce thepotential exposure to bloodand body fluids.This is asingleuse,disposabledevice(s), provided non-sterile. | The surgical face masks are intended to be wornto protect both the patient and healthcarepersonnel from transfer of microorganisms,body fluids and particulate material. These facemasks are intended for use in infection controlpractices to reduce the potential exposure toblood and body fluids. This is a single use,disposable device(s), provided non-sterile. | Same |
| ASTM Level | 1 | 1, 2 and 3 | Similar |
| Design Feature | Tie-on/Ear loop | Tie-on/ear loop | Same |
| Mask Style | 5 flat pleated | 3 flat pleated | Similar |
| Comparisonparameters | ALLURETM Surgical Maskby Allure Gift Wraps PvtLtd | Surgical Face Mask, Ear Loops (Model 101B,101G, 136B, 136G, 137B, 137G) and SurgicalFace Mask, Tie-on (Model 145B, 145G, 143B,143G, 138B, 138G, 142B, 142G) | Comparison |
| Mask | |||
| Duration and typeof contact | Direct contact, less than 24hours, skin contact | Direct contact, less than 24 hours, skin contact | Same |
| ProductPerformanceSpecifications | Meets:ASTM F1862/F1862M-17ASTM F2101-21ASTM F2100-19ASTM F2299-03ISO 10993-5: 2009ISO 10993-10: 2010EN 14683: 2019Meet 16 CFR Part 1610 | Meet ASTM F1862-07Meet ASTM F2101-07Meet ASTM F2299-03Meet MIL-M-36954CMeet 16 CFR Part 1610ISO 10993-5: 2009ISO 10993-10: 2010 | Similar |
| 16 CFR Part 1610Flammability Class | Class 1 | Class 1 | Same |
| Single Use | Yes | Yes | Same |
| Disposable | Yes | Yes | Same |
| Non-Sterile | Yes | Yes | Same |
| Material ofConstruction | Valve less, consisting of 5layers made up of breathablePP non-woven, hot airinsulation cotton, two layers ofmelt blown fabrics, non-wovenfabrics and plastic nose stripsand Elastic cord. | These are pleated 3 ply single use, disposablemasks. Inner layers and outer layers are made ofspun-bond polypropylene. Middle layer is madeof melt blown polypropylene filter. Ear loops areKnitted Elastic loops (not made with naturalrubber latex). Tie-on is made of spun-bondpolypropylene. The nose piece is a malleablealuminium wire. | Similar |
| Outer facing Layer | Breathable PP non-woven, hotair insulation cotton | Spun bond Polypropylene | Similar |
| Middle Layer | Meltblown Polypropylene | Meltblown Polypropylene | Similar |
| Comparisonparameters | ALLURE™ Surgical Maskby Allure Gift Wraps PvtLtd | Surgical Face Mask, Ear Loops (Model 101B,101G, 136B, 136G, 137B, 137G) and SurgicalFace Mask, Tie-on (Model 145B, 145G, 143B,143G, 138B, 138G, 142B, 142G) | Comparison |
| Inner facing layer | Skin friendly non-wovenfabrics | Spunbond Polypropylene | Similar |
| Binding | Spunbond Polypropylene | Spunbond Polypropylene | Similar |
| Nosepiece | Aluminium wire | Twisted metal strip | Similar |
| Earloop | Polyester | Cotton stretchable elastic type cord | Similar |
| Offered as fog free | NA | NA | Same |
| Offered with Visor | NA | NA | Same |
| Colour | White | Blue, Green | Different. |
| Dimension (width) | 105 ± 5 mm | 3.5" +/-0.25"4.2" +/-0.25" | Different. |
| Dimension (length) | 155 ± 5 mm | 6.8" +/-0.25" | Different. |
| Over the counteruse | Yes | Yes | Same |
| Biocompatibility | Non-cytotoxic, non-sensitizer,non-irritant | Non-cytotoxic, non-sensitizer, non-irritant | Same |
Table 5.1. Comparison of Characteristics
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Image /page/7/Picture/0 description: The image shows the logo for Allure Gift Wraps Pvt Ltd. The logo features a green bow on the left side and the word "ALLURE" in colorful blocks on the right side. Below "ALLURE" is the text "Gift Wraps" in a cursive font. Below the logo is the text "Allure Gift Wraps Pvt Ltd" in a larger font.
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Image /page/8/Picture/0 description: The image shows the logo for Allure Gift Wraps Pvt Ltd. The logo features a green bow on the left side and the word "ALLURE" in colorful blocks above the words "Gift Wraps" in cursive. Below the logo is the text "Allure Gift Wraps Pvt Ltd" in red.
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Image /page/9/Picture/0 description: The image shows the logo for Allure Gift Wraps Pvt Ltd. The logo features a colorful design with the word "ALLURE" in block letters, each letter in a different color. Below "ALLURE" is the text "Gift Wraps" in a cursive font. The logo also includes a green bow design on the left side.
The ALLURE™ Surgical Mask has similar indications for use statement as the predicate device and both devices have essentially the same intended use. The device also has similar technological characteristics as the predicate devices have similar material of construction and the same Product Performance Specifications.
5.8 Performance Data [21 CFR 807.92(b)]: Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b) (1)]
To verify that the ALLURE™ Surgical Mask meet the design requirements, testing was conducted in accordance with Surgical Masks - Premarket Notification [510(k)] Submission guidance, ASTM and ISO standards. Risk analysis was carried out in accordance with established inhouse acceptance criteria based on ISO 14971:2012.
The results of the performance testing using three non-consecutive lots demonstrate fulfilment of requirements as per device specific guidance Surgical Masks - Premarket Notification [510(k)] Submission as well as substantial equivalence with predicate.
| Testing/Standards | Purpose of the Test | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM F1862/F1862M-17Resistance of Medical FaceMask to Penetration bySynthetic blood | To determine the splashresistance/Fluid Penetration-Resistance to blood | Allure Surgical maskshould be resistant toPenetration bySynthetic blood | Pass. Allure facemask is resistantto Penetration bySynthetic blood |
| ASTM F2101-19EN 14683: 2014Bacterial FiltrationEfficiency | To determine the filtrationefficiency of Allure Surgicalmask by comparingthe bacterial control countsupstream of the AllureSurgical Mask to the bacterialcounts downstream | Bacterial FiltrationEfficiency should be>95.0% | Pass. FiltrationEfficiency wasfound to be>95.0% |
| ASTM F2101-19EN 14683: 2014Determination ofBreathability | To determine the Breathabilitytest (Differential Pressure Pa. | Level 1<5mmH2O/cm²Level 2<6mmH2O/cm²Level 3<6mmH2O/cm² | Pass. AllureFace maskmeets therequirement forLevel 1. |
Table 5.2. Non-Clinical Performance Tests
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Image /page/10/Picture/0 description: The image shows the logo for Allure Gift Wraps Pvt Ltd. The logo features a green bow on the left side and the word "ALLURE" in colorful blocks on the right side. Below the word "ALLURE" is the phrase "Gift Wraps" in a cursive font. Below the logo is the text "ALLURE GIFT WRAPS PVT LTD" in red.
| 16 CFR Part 1610Flammability | To determine the flammabilityas per 16 CFR Part 1610 | Allure Surgical maskshall meet the as perrequirements of Class 1Normal flammability | Pass. Allure facemask is found tobe of Class 1:Normalflammability |
|---|---|---|---|
| ASTM F2299 / F2299M -03(2017)Standard Test Method forDetermining the InitialEfficiency of Materials Usedin Medical Face Masks toPenetration by ParticulatesUsing Latex Spheres | To evaluate the non-viableparticle filtration efficiency(PFE) of the Allure SurgicalMask. | Particle FiltrationEfficiency Test at 0.1micron (%) should be>95% | Pass. Allureface mask meetsthe requirementfor Level 1 >95 |
Table 5.3. Biocompatibility Performance tests
| Category | Testing/Standards | Result |
|---|---|---|
| Test for in vitro cytotoxicity:Elution method. | ISO 10993-5:2009(E) | Based upon the results obtained in thisstudy and in line with ISO 10993-5:2009(E), it is concluded that the giventest item, ALLURETM Surgical Mask,supplied by Allure Gift Wraps Pvt Ltd, isnon-cytotoxic to Balb/c 3T3 cells. |
| Skin Sensitization Test inGuinea Pigs. (Guinea PigMaximization Test) | ISO 10993-10:2010(E) | Based upon the results obtained in thisstudy and in line with ISO 10993-10:2010(E), the given test item,ALLURETM Surgical Mask, supplied byAllure Gift Wraps Pvt Ltd, is considered asnon-sensitizer to Guinea Pigs. |
| Skin Irritation Test in NewZealand White Rabbits. | ISO 10993-10:2010(E) | Based upon the results obtained in thisstudy and in line with ISO 10993-10:2010(E), the given test item,ALLURETM Surgical Mask, suppliedAllure Gift Wraps Pvt Ltd, is considered asnon-irritant to New Zealand White Rabbits. |
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Image /page/11/Picture/0 description: The image shows the logo for Allure Gift Wraps Pvt Ltd. The logo features a green bow on the left side and the word "ALLURE" in colorful blocks on the right side. Below the word "ALLURE" is the phrase "Gift Wraps" in a cursive font. The words "ALLURE GIFT WRAPS PVT LTD" are printed in red below the logo.
ર.9 Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b) (2)]
There was no clinical testing required for this device.
5.10 Statement of Substantial Equivalence [21 CFR 807.92(b) (3)]
Conclusion
The conclusion drawn from the non-clinical performance tests demonstrates that the ALLURE™ Surgical Mask 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.