Cross Protection ResQ300 Plus Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transms, bodily fluids and particulate material.

Device Description

The Cross Protection® ResQ300 Plus Surgical Facemask is a pleated, multi-ply design, which is a nonsterile, single use, disposable device. The mask covers the nose and mouth and is secured to the face using the attached ear loops or attached ties.

The outer layer is made of 100% blue spun-bond polypropylene. The middle layer is filter media composed of 100% white melt-blown polypropylene. The inner (patient contacting) layer is made of either 100% white spun-bond polypropylene or 100% white medical grade tissue paper.

The ear attachments are either Ear Loop style. Ear Loops are made of elastic and the Tie-On straps are made of 100% white spun-bond polypropylene.

The nosepiece is made of malleable aluminum.

All materials used in the construction of the mask are being used in currently marketed devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cross Protection ResQ300 Plus Surgical Face Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Reported Device Performance (Result)	Met Criteria?
Biocompatibility:
Cytotoxicity (ISO 10993-5): 0 – None, 1 – Slight, 2 – Mild	Not cytotoxic – Mild reactivity	Yes
Primary Skin Irritation (ISO 10993-10): Negligible: 0 to 0.4	Negligible irritant	Yes
Sensitization (ISO 10993-10): 0 – No visible change	Non-sensitizing	Yes
Performance Testing (ASTM F2100 Level 1):
Bacterial Filtration Efficiency (BFE) (ASTM F2101-19): ≥ 95%	Level 1	Yes (≥ 95%)
Differential Pressure (Delta P) (EN14683): < 5.0 mm of H2O/cm²	Level 1	Yes (< 5.0)
Sub-micron Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03): ≥ 95%	Level 1	Yes (≥ 95%)
Synthetic Blood Penetration Resistance (ASTM F1862): 80 mmHg	Level 1	Yes (80 mmHg)
Flammability (16 CFR 1610): Class 1	Class 1	Yes

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test (e.g., how many masks were tested for BFE, PFE). However, the testing conducted is non-clinical bench testing, which means it does not involve human subjects or patient data. The provenance of the data is from laboratory testing performed according to the specified international and national standards (ISO, ASTM, EN, CFR).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the ground truth for this device (a surgical face mask) is established through standardized laboratory testing against objective performance criteria, not through expert human interpretation or consensus. The test results themselves serve as the 'ground truth' against the defined acceptance criteria.

4. Adjudication Method for the Test Set:

This information is not applicable. As mentioned above, the evaluation relies on objective laboratory measurements and does not involve human interpretation or adjudication processes like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable. This submission is for a surgical face mask, which is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance with human readers is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. As explained above, this device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established industry standards and objective laboratory measurements. For instance, the Bacterial Filtration Efficiency (BFE) is a measured percentage, and flammability is classified according to a specific standard. The results of these tests against predefined acceptance criteria from the standards constitute the "ground truth" for evaluating the mask's performance.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for a physical surgical face mask.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

August 17, 2022

Cross Protection (M) Sdn Bhd Grace Tan Operations Manager 11, JLN Perindustrian5, JLN Meru Klang, Selangor 41050 Malaysia

Re: K212273

Trade/Device Name: Cross Protection ResQ300 Plus Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 17, 2022 Received: June 17, 2022

Dear Grace Tan:

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 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,

Bifeng Qian M.D., 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212273

Device Name

Cross Protection ResQ300 Plus Surgical Face Mask

Indications for Use (Describe)

The Cross Protection ResQ300 Plus Surgical Face Masks are intended to be used as isolation face mask and dental face mask.

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: K212273

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

l. SUBMITTER

Applicant	Cross Protection (M) Sdn Bhd
Address	11, Jln Perindustrian 5, Batu 5 ½, Off Jln Hj AbdulManan, 41050 Klang, Selangor, Malaysia
Phone	603 3392 0000	Fax	603 3392 3867
Contact Person	Grace Tan	Title	Operations Manager
Date Prepared	August 12, 2022

II. PROPOSED DEVICE AND PREDICATE DEVICE

	New Device 807.92(a)(2)	Predicate Device 807.92(a)(3)
Proprietary Names/510(k) Number	ResQ300 Plus / K212273	Non-Sterile Surgical Face Mask /K051291
Manufacturer	Cross Protection (M) Sdn Bhd.	A.R. Medicom Inc.
Classification Code	FXX	FXX
Device Classification	2	2
Regulation Number	878.4040	878.4040
Panel	General and Plastic Surgery	General and Plastic Surgery
Device Classification Name	Mask, Surgical	Mask, Surgical
Common Name	Surgical Apparel	Surgical Apparel

lll. DEVICE DESCRIPTION

The ear attachments are either Ear Loop style. Ear Loops are made of elastic and the Tie-On straps are made of 100% white spun-bond polypropylene.

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The nosepiece is made of malleable aluminum.

All materials used in the construction of the mask are being used in currently marketed devices.

ResQ300 Plus model numbers:

Description	Product Code
ResQ300 Plus (Tie On)	2-406TO
ResQ300 Plus (Earloop)	2-406EL

IV. INDICATIONS FOR USE

The Cross Protection ResQ300 Plus Surgical Face Mask is intended to be used as an isolation face mask, procedure mask, and dental face mask.

Cross Protection ResQ300 Plus Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the opersonnel from transfer of micro-organisms, bodily fluids and particulate material.

V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

	Proposed Device	Predicate Device	Result
510(K) Number	K212273	K051291
Device Name	ResQ300 Plus SurgicalFacemask	Non-Sterile Surgical Mask
Manufacturer	Cross Protection (M) Sdn Bhd	A.R. Medicom Inc.
Classification	Class 2	Class 2	Same
Product Code	FXX	FXX	Same
Regulation No.	878.4040	878.4040	Same
Indications for Use	The Cross Protection® ResQ300Plus Surgical Facemask isintended to be used as isolationface mask, procedure mask anddental face mask.It is intended to be worn byoperating room personnelduring surgical proceduresto protect both the surgicalpatient and the operatingpersonnel from transfer ofmicro-organisms, bodyfluids and particulatematerial.	The medical/surgical masksare indicated as a protectivenose and mouth covering forhealth care workers andpatients involved in medicaland surgical procedures.The masks are indicated inany procedure or situationwhere there is a risk ofmicroorganism, body fluid,and particulate aerosoltransfer.	Similar
	Proposed Device	Predicate Device	Result
Over-the-Counter Use	Yes	Yes	Same
Sterile	No	No	Same
Single-Use	Yes	Yes	Same
Dimensions
Body Length	185mm (7.0")	175mm (6.8")	Similar
Body Width	90.0mm (3.5")	90.5mm (3.5")	Similar
Ear Loop	150mm ( 5.9")	165mm (6.5")	Similar
Ear Tie	900mm (35.4")	N/A	Different
Nose Piece Length	94mm (3.7")	105 mm (4.1")	Similar
Description	Pleated, 3-ply rectangular facemasks with a shapeablenosepiece and two earloops (orties) present, one on each side,in order to hold mask in place.	Shingle pleats rectangularface masks with a shapeablenosepiece and two earloopspresent, one on each side, inorder to hold mask in place.	Similar
Inner Layer (PatientContacting)	Spun Bond Polypropylene ormedical grade tissue paper,white color	Spun Bond Polypropylene ormedical grade tissue paper,white color	Same
Middle Layer (FilterMedia)	Melt-blownPolypropylene, whitecolor	Melt-blown Polypropylene,white color	Same
Outer Layer	Spun Bond Polypropylene, bluecolor	Spun Bond Polypropylene,blue color	Same
Nose Piece	Malleable Aluminum	Malleable Aluminum	Same
Ear Attachments
Ear Loops	100% Flat-type Cottonand Elastic	Flat latex and fiberglass-freeelastic	Similar
Ear Ties	Spun-bond Polypropylene	N/A	Different
Biocompatibility Testing
Cytotoxicity ISO 10993-5	Not cytotoxic	Not cytotoxic	Same
Irritation ISO 10993-10	Non-irritating	Non-irritating	Same
Sensitization ISO 10993-10	Non-sensitizing	Non-sensitizing	Same
ASTM F2100 Level	1	1	Same
Performance Testing -Bench
ASTM F2101 BacterialFiltration Efficiency (BFE)	BFE @ 3.0 µm large Bacteria ≥95%	BFE @ 3.0 µm large Bacteria> 95%	Same
	Proposed Device	Predicate Device	Result
EN14683 DifferentialPressure (Delta P)	ΔP < 5.0 mm of H2O/cm2	ΔP < 5.0 mm of H2O/cm²	Same
ASTM F2299 ParticulateFiltration Efficiency (PFE)	PFE @ 0.1 µm large Latexparticles ≥ 95%	PFE @ 0.1 µm large Latexparticles ≥ 95%	Same
ASTM F1862 FluidResistance (SyntheticBlood)	Resistant @ 80mmHg	Resistant @ 80mmHg	Same
Textile Flammability16 CFR 1610	Class I	Class I	Same
Performance Testing -Animal	None	Unknown	Unknown
Performance Testing -Clinical	None	Unknown	Unknown

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Substantial Equivalence Discussion:

The above comparison table shows that ResQ300 Plus Surgical Face Masks are similar in design, intended use, and function to the A.R. Medcom Surgical Face Masks. There are a few differences:

The ResQ300 Plus Surgical Face masks are slightly longer than the A.R. Medicom Surgical Face Masks in surface area (185mm vs 175mm), which provides better facial coverage for adult-size faces.
The ResQ300 Plus ear loops are slightly smaller (150mm vs 160mm) than the A.R. Medicom ear loops and provide a tighter, more secure, hold.
The ResQ300 Plus masks have a tie-on option that is not offered in the A.R. Medicom Surgical Face Mask, which provides comfort for people who may be uncomfortable with elastic loops on their ears.
The ResQ300 Plus nose piece is smaller (94mm vs 105mm), which makes fitting to the nose area more precise.

All materials used in the ResQ300 Plus Surgical Face masks are used in currently marketed devices. Biocompatibility and performance bench-testing demonstrate that the ResQ300 Plus Surgical Face Masks meet FDA requirements and that there are no new concerns of safety and effectiveness.

VI. SUMMARY OF NON-CLINICAL TESTNG

The ResQ300 Plus Surgical Face Mask was tested for biocompatibility and performance as shown in the below tables.

Biocompatibility Testing

CROSS PROTECTION RESQ300 PLUS

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The ResQ300 Plus Surgical Face Mask was tested according to the below ISO 10993 biocompatibility testing standards and test results show that the device presents no new safety risk when compared with the predicate device.

Test Name	Standard	Pass Criteria	Results
Cytotoxicity – MEM Elution Test	ISO 10993-5	0 – None1 – Slight2 – Mild	Not cytotoxic –Mild reactivity
Primary Skin Irritation Test	ISO 10993-10	Negligible: 0 to 0.4	Negligibleirritant
Maximization Test for Delayed-TypeHypersensitivity in Hartley Guinea Pigs	ISO 10993-10	0 – No visible change	Non-sensitizing

Performance Testing – Bench

The ResQ300 Plus Surgical Face Mask was tested according to the below performance standards and test results show that the device presents no new safety risk when compared with the predicate device.

Test Name	Standard	Pass Criteria	Results
Bacterial Filtration Efficiency (BFE)	ASTM F2100-19 Clause 9.1,ASTM F2101-19	Level 1: ≥ 95%Level 2: ≥98Level 3: ≥98	Level 1
Differential Pressure (Delta P),mmH20/cm²	ASTM F2101, EN14683	Level 1: <5.0Level 2: <6.0Level 3: <6.0	Level 1
Sub-micron particulate filtrationefficiency (PFE)	ASTM F2100-19 Clause 9.3,ASTM F2299/F2299M-03	Level 1: ≥ 95%Level 2: ≥98%Level 3: ≥98%	Level 1
Synthetic Blood PenetrationResistance (mmHg)	ASTM F1862	Level 1: 80Level 2: 120Level 3: 160	Level 1
Flammability	ASTM F2100-19 Clause 9.5,16 CFR 1610	Class 1	Class 1

Animal Testing

Not applicable

SUMMARY OF CLINICAL TESTING VII.

Not applicable

VIII. CONCLUSION

The conclusions drawn from the non-clinical testing demonstrates that the Cross Protection ResQ300 Plus Surgical Face Masks are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K051291.

Regulation Number and Section

§ 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.