(367 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
This device is a surgical mask intended to prevent the transfer of microorganisms and particulate material, not to treat or cure a disease or condition.
No
The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (PP non-woven, hot air insulation cotton, melt blown fabrics, plastic nose strips, elastic cord) and the performance studies focus on physical properties and filtration efficiency, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers of fabric, nose strip, elastic cord). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as resistance to penetration, filtration efficiency, breathability, flammability, and biocompatibility. These are tests related to the mask's ability to act as a barrier and be safely worn, not diagnostic performance metrics.
- Key Metrics: The key metrics listed (Bacterial Filtration Efficiency, Particle Filtration Efficiency) are measures of the mask's filtering capabilities, not diagnostic accuracy metrics like sensitivity, specificity, PPV, or NPV.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Surgical masks do not perform this function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
healthcare personnel / In a hospital or clinic environment, Operating room.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the ALLURE™ Surgical Mask met design requirements, following "Surgical Masks - Premarket Notification [510(k)] Submission" guidance, ASTM, and ISO standards. Risk analysis was carried out based on ISO 14971:2012.
The performance testing results from three non-consecutive lots showed fulfillment of requirements as per the device specific guidance and substantial equivalence with the predicate.
Key performance tests and their results:
- ASTM F1862/F1862M-17 Resistance of Medical Face Mask 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: Pass. Filtration Efficiency was found to be >95.0%.
- ASTM F2101-19 EN 14683: 2014 Determination of Breathability: Pass. Allure Face mask meets the requirement for Level 1 (95% (Particle Filtration Efficiency Test at 0.1 micron).
Biocompatibility Performance tests:
- Test for in vitro cytotoxicity: Elution method (ISO 10993-5:2009(E)): Concluded that the ALLURE™ Surgical Mask is non-cytotoxic to Balb/c 3T3 cells.
- Skin Sensitization Test in Guinea Pigs (Guinea Pig Maximization Test) (ISO 10993-10:2010(E)): Considered as non-sensitizer to Guinea Pigs.
- Skin Irritation Test in New Zealand White Rabbits (ISO 10993-10:2010(E)): Considered as non-irritant to New Zealand White Rabbits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial Filtration Efficiency: >95.0%
- Breathability (Differential Pressure): 95%
- Flammability: Class 1
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
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) | ☑ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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)
4
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
5
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.
6
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.
| Comparison
parameters | ALLURETM Surgical Mask
by Allure Gift Wraps Pvt
Ltd | Surgical Face Mask, Ear Loops (Model 101B,
101G, 136B, 136G, 137B, 137G) and Surgical
Face 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 Surgical
Face Mask, Tie-on, (Model 145B, 145G, 143B,
143G, 138B, 138G, 142B, 142G, 151B, 151G) | Different |
| Indications for Use | 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. | The surgical face 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. | 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 |
| Comparison
parameters | ALLURETM Surgical Mask
by Allure Gift Wraps Pvt
Ltd | Surgical Face Mask, Ear Loops (Model 101B,
101G, 136B, 136G, 137B, 137G) and Surgical
Face Mask, Tie-on (Model 145B, 145G, 143B,
143G, 138B, 138G, 142B, 142G) | Comparison |
| | | | Mask |
| Duration and type
of contact | Direct contact, less than 24
hours, skin contact | Direct contact, less than 24 hours, skin contact | Same |
| Product
Performance
Specifications | Meets:
ASTM F1862/F1862M-17
ASTM F2101-21
ASTM F2100-19
ASTM F2299-03
ISO 10993-5: 2009
ISO 10993-10: 2010
EN 14683: 2019
Meet 16 CFR Part 1610 | Meet ASTM F1862-07
Meet ASTM F2101-07
Meet ASTM F2299-03
Meet MIL-M-36954C
Meet 16 CFR Part 1610
ISO 10993-5: 2009
ISO 10993-10: 2010 | Similar |
| 16 CFR Part 1610
Flammability Class | Class 1 | Class 1 | Same |
| Single Use | Yes | Yes | Same |
| Disposable | Yes | Yes | Same |
| Non-Sterile | Yes | Yes | Same |
| Material of
Construction | 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. | These are pleated 3 ply single use, disposable
masks. Inner layers and outer layers are made of
spun-bond polypropylene. Middle layer is made
of melt blown polypropylene filter. Ear loops are
Knitted Elastic loops (not made with natural
rubber latex). Tie-on is made of spun-bond
polypropylene. The nose piece is a malleable
aluminium wire. | Similar |
| Outer facing Layer | Breathable PP non-woven, hot
air insulation cotton | Spun bond Polypropylene | Similar |
| Middle Layer | Meltblown Polypropylene | Meltblown Polypropylene | Similar |
| Comparison
parameters | ALLURE™ Surgical Mask
by Allure Gift Wraps Pvt
Ltd | Surgical Face Mask, Ear Loops (Model 101B,
101G, 136B, 136G, 137B, 137G) and Surgical
Face Mask, Tie-on (Model 145B, 145G, 143B,
143G, 138B, 138G, 142B, 142G) | Comparison |
| Inner facing layer | Skin friendly non-woven
fabrics | 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 counter
use | Yes | Yes | Same |
| Biocompatibility | Non-cytotoxic, non-sensitizer,
non-irritant | Non-cytotoxic, non-sensitizer, non-irritant | Same |
Table 5.1. Comparison of Characteristics
7
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.
8
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.
9
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-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 195% | Pass. Allure
face mask meets
the requirement
for 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 this |
| study and in line with ISO 10993- | ||
| 5:2009(E), it is concluded that the given | ||
| test item, ALLURETM Surgical Mask, | ||
| supplied by Allure Gift Wraps Pvt Ltd, is | ||
| non-cytotoxic to Balb/c 3T3 cells. | ||
| Skin Sensitization Test in | ||
| Guinea Pigs. (Guinea Pig | ||
| Maximization Test) | ISO 10993-10:2010(E) | Based upon the results obtained in this |
| study and in line with ISO 10993- | ||
| 10:2010(E), the given test item, | ||
| ALLURETM Surgical Mask, supplied by | ||
| Allure Gift Wraps Pvt Ltd, is considered as | ||
| non-sensitizer to Guinea Pigs. | ||
| Skin Irritation Test in New | ||
| Zealand White Rabbits. | ISO 10993-10:2010(E) | Based upon the results obtained in this |
| study and in line with ISO 10993- | ||
| 10:2010(E), the given test item, | ||
| ALLURETM Surgical Mask, supplied | ||
| Allure Gift Wraps Pvt Ltd, is considered as | ||
| non-irritant to New Zealand White Rabbits. |
11
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.