(393 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
A surgical face mask is a barrier device intended to protect operating room personnel and patients from the transfer of microorganisms, bodily fluids, and particulate material. It is a protective device, not a device that treats or diagnoses a disease or condition.
No
Explanation: The device is a surgical face mask intended to protect personnel and patients from bodily fluids and particulate material during surgical procedures. Its function is barrier protection, not diagnosis. The performance studies and key metrics listed (filtration efficiency, pressure, blood penetration, flammability) are related to its protective capabilities, not diagnostic measurement.
No
The device description clearly outlines physical components like polypropylene layers, aluminum nosepiece, and elastic ear loops, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect both the patient and the personnel from the transmission of bodily fluids and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of a surgical face mask. 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 and filtration capabilities of the mask (BFE, PFE, blood penetration, flammability), not on the accuracy or reliability of a diagnostic test.
- Key Metrics: The key metrics are related to the mask's ability to filter particles and resist fluid penetration, not diagnostic performance metrics like sensitivity or specificity.
IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This surgical face mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Cross Protection ResQ300 Plus Surgical Face Masks are intended to be used as isolation face 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 operating personnel from transms, bodily fluids and particulate material.
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
ResQ300 Plus model numbers:
Description: ResQ300 Plus (Tie On), Product Code: 2-406TO
Description: ResQ300 Plus (Earloop), Product Code: 2-406EL
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
Not Found
Intended User / Care Setting
Operating room personnel during surgical procedures.
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)
The ResQ300 Plus Surgical Face Mask was tested for biocompatibility and performance.
Biocompatibility Testing:
- Cytotoxicity – MEM Elution Test (ISO 10993-5): Results indicated "Not cytotoxic – Mild reactivity".
- Primary Skin Irritation Test (ISO 10993-10): Results indicated "Negligible irritant".
- Maximization Test for Delayed-Type Hypersensitivity in Hartley Guinea Pigs (ISO 10993-10): Results indicated "Non-sensitizing".
Performance Testing – Bench:
- Bacterial Filtration Efficiency (BFE) (ASTM F2100-19 Clause 9.1, ASTM F2101-19): Achieved Level 1 performance (≥ 95%).
- Differential Pressure (Delta P), mmH20/cm² (ASTM F2101, EN14683): Achieved Level 1 performance (
§ 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.
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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
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 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.
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.
| 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 Abdul | ||
| Manan, 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 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.
4
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 Surgical | ||
| Facemask | 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® ResQ300 | ||
| Plus Surgical Facemask is | |||
| intended to be used as isolation | |||
| face mask, procedure mask and | |||
| dental face mask. | |||
| It is intended to be worn by | |||
| operating room personnel | |||
| during surgical procedures | |||
| to protect both the surgical | |||
| patient and the operating | |||
| personnel from transfer of | |||
| micro-organisms, body | |||
| fluids and particulate | |||
| material. | The medical/surgical masks | ||
| are indicated as a protective | |||
| nose and mouth covering for | |||
| health care workers and | |||
| patients involved in medical | |||
| and surgical procedures. | |||
| The masks are indicated in | |||
| any procedure or situation | |||
| where there is a risk of | |||
| microorganism, body fluid, | |||
| and particulate aerosol | |||
| transfer. | 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 face | ||
| masks with a shapeable | |||
| nosepiece and two earloops (or | |||
| ties) present, one on each side, | |||
| in order to hold mask in place. | Shingle pleats rectangular | ||
| face masks with a shapeable | |||
| nosepiece and two earloops | |||
| present, one on each side, in | |||
| order to hold mask in place. | Similar | ||
| Inner Layer (Patient | |||
| Contacting) | Spun Bond Polypropylene or | ||
| medical grade tissue paper, | |||
| white color | Spun Bond Polypropylene or | ||
| medical grade tissue paper, | |||
| white color | Same | ||
| Middle Layer (Filter | |||
| Media) | Melt-blown | ||
| Polypropylene, white | |||
| color | Melt-blown Polypropylene, | ||
| white color | Same | ||
| Outer Layer | Spun Bond Polypropylene, blue | ||
| color | Spun Bond Polypropylene, | ||
| blue color | Same | ||
| Nose Piece | Malleable Aluminum | Malleable Aluminum | Same |
| Ear Attachments | |||
| Ear Loops | 100% Flat-type Cotton | ||
| and Elastic | Flat latex and fiberglass-free | ||
| elastic | 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 Bacterial | |||
| Filtration Efficiency (BFE) | BFE @ 3.0 µm large Bacteria ≥ | ||
| 95% | BFE @ 3.0 µm large Bacteria |
95% | Same |
| | Proposed Device | Predicate Device | Result |
| EN14683 Differential
Pressure (Delta P) | ΔP