(88 days)
Not Found
No
The device description and performance studies focus solely 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 primarily intended to prevent the transfer of microorganisms and body fluids, acting as a barrier for infection control rather than to cure or treat a disease or condition in the user.
No
The device, a surgical face mask, is described as a protective barrier against microorganisms and fluids, not as a tool for diagnosing medical conditions. Its intended use is for infection control and protection, not for detecting, monitoring, or identifying diseases or conditions.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene filter, nose wire, ear loops/tie-on strings) and the performance studies focus on physical properties and filtration efficiency, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is 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 in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, materials, nose wire, ear loops/ties). This aligns with a physical barrier device, not a diagnostic instrument or reagent.
- Lack of Diagnostic Elements: There is no mention of any components, reagents, or processes that would be used to analyze samples (like blood, urine, tissue) to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility). These are relevant to a protective barrier device, not an IVD.
- Predicate Device: The predicate device listed is a "Disposable Surgical Face Mask," which is consistent with a non-IVD device.
In summary, the device's function is to act as a physical barrier to prevent the transfer of substances, which is the definition of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The surgical face mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face masks are in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only,
Available models: Surgical Face Mask EL (Ear loops) Surgical Face Mask TO (Tie-on)
Product codes
FXX
Device Description
The CPL Surgical Face Mask is a 3-ply flat-pleated mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core galvanized wire.
The model Surgical Face Mask EL is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of braided elastic band. The model Surgical Face Mask TO is provided with non-woven tie-on string.
The dimensions of the test item are: length- 175 ± 5 mm and width- 95 ± 5 mm. The ear loop length of the model Surgical Face Mask EL is 170± 5 mm. The tie-on of the model Surgical Face Mask TO has a top strap length of 410 ± 10 mm and bottom strap length of 385 ± 10 mm.
The surgical masks are single-use, disposable devices, provided non-sterile.
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
patient and healthcare personnel
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: Non-Clinical Data
Sample Size: Not specified, "3 nonconsecutive lots"
Standalone Performance: The device was subjected to performance tests including Fluid resistance, Bacterial filtration efficiency, Particulate filtration efficiency, Differential pressure, and Flammability, according to ASTM and EN standards. Biocompatibility tests (In-vitro Cytotoxicity, Skin irritation, Skin Sensitization) were also performed according to ISO standards.
Key Results:
Fluid resistance: Pass at 160 mmHg for both models (EL and TO). Acceptance criteria: Pass at 160 mmHg.
Particulate Filtration Efficiency (PFE): >98% for both models. Acceptance criteria: ≥ 98%.
Bacterial Filtration Efficiency (BFE): >98% for both models. Acceptance criteria: ≥ 98%.
Differential pressure (ΔΡ):
§ 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 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 ADMINISTRATION" in blue text.
December 24, 2021
Control Print Limited % Manoj Zacharias US Agent Liberty Management Group Ltd. 75 Executive Drive, Suite 114 Aurora, Illinois 60504
Re: K213136
Trade/Device Name: CPL Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: September 20, 2021 Received: September 27, 2021
Dear Manoj Zacharias:
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
542 of the Act); 21 CFR 1000-1050.
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-
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213136
Device Name CPL Surgical Face Mask
Indications for Use (Describe)
The surgical face mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face masks are in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only,
Available models: Surgical Face Mask EL (Ear loops) Surgical Face Mask TO (Tie-on)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Control Print. The words "CONTROL" and "PRINT" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a graphic of four red circles of varying sizes, arranged in a diagonal line. The largest circle is at the top, and the smallest circle is at the bottom.
510(k) Summary (K213136)
[AS REQUIRED BY 21CFR807.92]
APPLICANT INFORMATION I.
| Submitter's Name | Control Print Limited |
|---|---|
| Submitter's Address | Village Bhatian, Near TVS Factory, Bharatgarh Road, |
| Nalagarh, District Solan -174101, | |
| Himachal Pradesh, India | |
| Name of Contact Person | Mr. Pankaj Sharma |
| Designation | Manager Quality Assurance |
| Division Name of Contact Person | Quality Management |
| Contact Number | 91 9805020592 |
| Contact E-mail | nalagarhqm@controlprint.com |
| Date of Summary Prepared | 22 December 2021 |
II. DEVICE DETAILS
| Device Trade Name | CPL Surgical Face Mask |
|---|---|
| Device Common Name | Surgical Face Mask |
| Model(s) | Surgical Face Mask EL, Surgical Face Mask TO |
| Device Classification name | Mask, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |
Page 1 of 8
Control Print Limited, Village Bhalian, Near TVS Factory, Bharatgarh 174101, Dist. Solan, Himachal Pradesh, India t. +91 9816620580 / 9805020580 / 81 / 82 | e. nalagarh@controlprint.com | w. www.controlprint.com CIN. L22219MH1991PLC059800
MUMBAI (Regd.Office) · AHMEDABAD · CHANDIGARH · CHENNAI · COLOMBO · DELHI · GUWAHATI HYDERABAD · JAMSHEDPUR · KERALA · KOLKATA · NEPAL · PUNE
4
Image /page/4/Picture/0 description: The image shows the logo for Control Print. The logo is composed of the words "CONTROL" and "PRINT" stacked on top of each other in a bold, sans-serif font. To the right of the text is a series of four red circles arranged in a diagonal line. The circles appear to be of slightly different sizes, with the largest circle in the middle.
PREDICATE DEVICE DETAILS III.
| Device Trade Name | Disposable Surgical Face Mask |
|---|---|
| Device Manufacturer Name | Anhui Jiabao Protective Equipments Co., Ltd |
| Model(s) | JB-DMO3 (Ear Loops), JB-DMO4 (Tie on) |
| 510(k) Number | K203801 |
| Regulation Number | 21 CFR 878.4040 |
| Device Class | Class II |
| Product Code | FXX |
DEVICE DESCRIPTION IV.
The CPL Surgical Face Mask is a 3-ply flat-pleated mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core galvanized wire.
The model Surgical Face Mask EL is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of braided elastic band. The model Surgical Face Mask TO is provided with non-woven tie-on string.
The dimensions of the test item are: length- 175 ± 5 mm and width- 95 ± 5 mm. The ear loop length of the model Surgical Face Mask EL is 170± 5 mm. The tie-on of the model Surgical Face Mask TO has a top strap length of 410 ± 10 mm and bottom strap length of 385 ± 10 mm.
The surgical masks are single-use, disposable devices, provided non-sterile.
V. INTENDED USE
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.
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Image /page/5/Picture/0 description: The image contains the logo for Control Print. The words "CONTROL" and "PRINT" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a graphic of four red circles in a curved line, with the top circle being the largest and the bottom circle being the smallest. The logo is simple and modern, and the red circles add a pop of color.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE
Table 1: General Comparison
| SI.
No | Features
compared | Proposed Device | Predicate Device | Result | | | |
|----------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|------------|--|
| | General Information | | | | | | |
| 1. | 510(k) Number | K213136 | K203801 | - | | | |
| 2. | Manufacturer | Control Print Limited | Anhui Jiabao Protective
Equipments Co., Ltd | - | | | |
| 3. | Common Name | Surgical face mask | Surgical face mask | Same | | | |
| 4. | Classification Name | Mask, Surgical | Mask, Surgical | Same | | | |
| 5. | Classification and
Regulation number | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Same | | | |
| 6. | Product Code | FXX | FXX | Same | | | |
| 7. | Indications For Use | The surgical face mask are
intended to be worn to protect
both the patient and healthcare
personnel
from transfer
of
microorganisms, body fluids and
particulate material. The face
masks are intended for use in
infection control practices to
reduce the potential exposure to
blood & body fluid. This device
is disposable, non-sterile and for
single use only.
Available models:
Surgical Face Mask EL (Ear
loops)
Surgical Face Mask TO (Tie-
on) | The Disposable Surgical Face
Mask is intended to be worn to
protect both the patient and
healthcare
personnel
from
of
transfer
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 a single use,
disposable device(s), provided
non-sterile. | Same | | | |
| SI.
No | Features
compared | Proposed Device | Predicate Device | Result | | | |
| 8. | Model specifications | Surgical Face Mask EL(3 ply flatpleated masks with ear loops)
Surgical Face Mask TO (3 ply
flat-pleated masks with tie-on) | JB-DM03(Ear Loops, Flat
Pleated, 3 layers)
JB-DM04(Tie-On, Flat Pleated,
3 layers) | Same | | | |
| | Materials | | | | | | |
| 9. | Outer layer | Spun bond polypropylene | Spun bond polypropylene | Same | | | |
| 10. | Filter layer | Melt blown polypropylene | Melt blown polypropylene filter | Same | | | |
| 11. | Inner layer | Spun bond polypropylene | Spun bond polypropylene | Same | | | |
| 12. | Nose wire | Polypropylene coated single
core galvanized wire | PE and iron | Different¹ | | | |
| 13. | Ear loop/ Tie-on | For model: Surgical Face
Mask EL
Ear Loop: Braided Elastic Band
For model: Surgical Face
Mask TO
Tie-on: Non-woven tie-on
string | For model: JB-DM03
Ear Loop: Nylon and spandex
For model: JB-DM04
Tie-on: Spun-bond
polypropylene | Different² | | | |
| 14. | Mask color | Blue | Blue | Same | | | |
| 15. | Dimensions | Length- 175 ± 5 mm
Width- 95 ± 5 mm
For model: Surgical Face
Mask EL
Ear Loop Length: 170± 5 mm
For model: Surgical Face
Mask TO
Tie-on strap length
- Top: 410 ± 10 mm
Bottom : 385 ± 10 mm | Length- 175 ± 5 mm
Width- 95 ± 5 mm | Same | | | |
| SI.
No | Features
compared | Proposed Device | Predicate Device | Result | | | |
| 16. | OTC Use | Yes | Yes | Same | | | |
| 17. | Sterility | Non-sterile | Non-sterile | Same | | | |
| 18 | Reusability | Single use | Single use | Same | | | |
| 19 | ASTM F2100 Level | Level 3 | Level 2 & 3 | Similar | | | |
| Non Clinical Testing | | | | | | | |
| Tests Performed | | Model No .:
Surgical
Face Mask
EL | Model No.:
Surgical
Face Mask
TO | Model No .:
JB-DM03
(Ear loop
model) | Model No.:
JB-DM04
(Tie-on
model) | Result | |
| 20. | Fluid resistance | Pass at 160
mmHg | Pass at 160
mmHg | Pass at 120
mmHg | Pass at 160
mmHg | Different3 | |
| 21. | Flammability | Class 1 | Class 1 | Class 1 | Class 1 | Same | |
| 22. | Particulate Filtration
Efficiency (PFE) | ≥ 98% | ≥ 98% | ≥ 98% | ≥ 98% | Same | |
| 23. | Bacterial Filtration
Efficiency (BFE) | ≥ 98% | ≥ 98% | ≥ 98% | ≥ 98% | Same | |
| 24. | Differential pressure
(ΔΡ) | 98% | >98% | ≥ 98% | Pass |
| 3. | Bacterial Filtration
Efficiency (BFE)
ASTM F2101-19 | > 98% | > 98% | ≥ 98% | Pass |
| 4. | Differential pressure
(ΔΡ)
EN 14683 (Annex C):
2019 |