Procedure Mask
Device Facts
| Record ID | K220377 |
|---|---|
| Device Name | Procedure Mask |
| Applicant | Little Rapids Corporation |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Jun 24, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Procedure 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. All models are single use, disposable devices, provided nonsterile.
Device Story
Procedure Masks (models GFM31A, GFM42A, GFM43A) are single-use, disposable face masks designed for infection control. GFM31A features three layers (polypropylene spunbond/meltblown/spunbond); GFM42A and GFM43A feature four layers. Models include welded ear loops and a PVC-coated nose wire for fit (GFM31A also offers an MRI-safe version without a nose wire). Masks are worn by healthcare personnel or patients to provide a physical barrier against microorganisms, body fluids, and particulates. They are used in clinical settings to reduce cross-contamination and exposure to blood/body fluids. Effectiveness is verified through ASTM F2100 performance standards, including fluid resistance, bacterial filtration efficiency, and particulate filtration efficiency.
Clinical Evidence
No clinical data. Bench testing only, including fluid resistance (ASTM F1862), particulate filtration (ASTM F2299), bacterial filtration (ASTM F2101), differential pressure (EN 14683), flammability (16 CFR 1610), and biocompatibility (ISO 10993).
Technological Characteristics
Materials: Polypropylene spunbond (outer/inner layers), polypropylene meltblown (filter layer), nylon/spandex ear loops, PVC-coated steel nose wire. Design: 3-layer (GFM31A) or 4-layer (GFM42A, GFM43A) flat-pleated construction. Non-sterile, single-use, latex-free. Performance meets ASTM F2100 levels 1, 2, or 3 depending on model.
Indications for Use
Indicated for patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Surgical Mask Model KC200 (K111402)
- Disposable Medical Mask Model Y01 (K202137)
- Surgical Mask Model KC300 (K111402)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2022
Little Rapids Corporation Tom Diedrich Manager of Product Development and Quality 2273 Larsen Road Green Bay, Wisconsin 54303
Re: K220377
Trade/Device Name: Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: Mav 25, 2022 Received: May 31, 2022
Dear Tom Diedrich:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
K220377
Device Name Procedure Mask
Indications for Use (Describe)
The Procedure 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. All models are single use, disposable devices, provided nonsterile.
| 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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K220377 Page 1 of 12
## 510(k) Summary
Date Prepared: June 17, 2022
# A. Applicant:
LITTLE RAPIDS CORPORATION Address: 2273 Larsen Road Green Bay, WI 54303
#### Submission Correspondent(s):
#### Primary contact: Tom Diedrich
Address: 2273 Larsen Road P.O. Box 19031 Green Bay, WI 54307-9031 Office Phone: (920) 490-5302 Email: tdiedrich@littlerapids.com
#### Secondary contact: David Ledvina
Address: 2273 Larsen Road P.O. Box 19031 Green Bay, WI 54307-9031 Office Phone: (920) 490-5315 Email: dledvina@littlerapids.com
### B. Device:
Device Name: Procedure Mask Intended Branding: Graham Medical Models: GFM31A (including MR Safe version), GFM42A, GFM43A
#### Regulatory Information:
Classification Name: Mask, Surgical Regulation Description: Surgical Apparel Regulation Specialty: General & Plastic Surgery Review Panel: General Hospital Product code: FXX Classification: Class II Regulation Number: 21 CFR 878.4040
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# C. Device Description:
- . Model GFM31A Procedure Mask will be provided with a nose wire for general medical use, and without a nose wire for use in an MRI environment. This model of Procedure Mask is manufactured with three layers. The user facing layer is made of white polypropylene spunbond; the filtration/middle layer is made of white polypropylene meltblown; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire, when present, is used to fit the facemask around the user's nose. The product intended to be used in an MRI environment is constructed with the same materials except for the nose wire. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
- Model GFM42A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
- Model GFM43A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
# D. Indications for use of the device:
The Procedure 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. All models are single use, disposable devices, provided non-sterile.
# E. Shelf Life
A shelf-life is not applicable to this product because of low likelihood of time-dependent degradation.
# F. Labeling - Instructions for Use
Procedure Masks have commonly known directions for use and fall under the exemption for Instructions for Use under 21CFR Chapter 1 Subchapter H part 801 Subpart D Sec 801.116.
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## G. Predicate Devices:
#### ● Model GFM31A – ASTM Level 1 Primary Predicate
510K Number: K111402 Kimberly Clark Corporation Device Name: Surgical Mask Model: KC200 (ASTM Level 2)
- Model GFM42A ASTM Level 2 ● Primary Predicate
510K Number: K111402 Kimberly Clark Corporation Device Name: Surgical Mask Model: KC200 (ASTM Level 2)
- Model GFM43A ASTM Level 3 ● Primary Predicate
510K Number: K111402 Kimberly Clark Corporation Device Name: Surgical Mask Model: KC200 (ASTM Level 2)
## Additional Predicate
510K Number: K202137 U-Play Products Corporation Device Name: Disposable Medical Mask Model: Y01 (ASTM Level 1)
## Additional Predicate
510K Number: K111402 Kimberly Clark Corporation Device Name: Surgical Mask Model: KC300 (ASTM Level 3)
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# H. Comparisons with Predicate Devices:
## Model GFM31A – ASTM Level 1
| | Proposed Device | Primary Predicate | Additional Predicate | Result |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Manufacturer | Little Rapids Corporation | Kimberly Clark<br>Corporation | U-Play Products<br>Corporation | - |
| 510K Number | K220377 | K111402 | K202137 | - |
| Product Common<br>Name(s) | Procedure Mask | Surgical Mask | Disposable Medical Mask | Similar |
| Model Number | GFM31A | KC200 | Y01 | - |
| Classification | Class II Device, FXX (21<br>CFR878.4040) | Class II Device, FXX (21<br>CFR878.4040) | Class II Device, FXX (21<br>CFR878.4040) | Same |
| Intended Use | The Procedure Masks are<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and body<br>fluids. Both models are<br>single use, disposable<br>devices, provided non-<br>sterile. | The Kimberly-Clark, K0200<br>and KC300 Face Mask(s) is<br>intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids, particulate material.<br>These face masks are<br>intended for use in<br>infection control practices<br>to reduce the potential<br>exposure of the wearer to<br>blood and body fluids. The<br>KC200 and KC300 face<br>mask(s) is a single use,<br>disposable device(s),<br>provided non-sterile. | The Disposable Medical<br>Masks are intended to be<br>worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body<br>fluids and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and<br>body fluids. This is a single<br>use, disposable device(s),<br>provided non-sterile. | Same |
| Design Features | Ear Loops, Flat Pleated, 3<br>layers, Nose Piece or No<br>Nose Piece | 4 Ply, Ear Loops, Flat-<br>Pleated or Tie-On Style | Ear Loops, Flat Pleated, 3<br>layers | Similar |
| Materials & Design | | | | |
| Outer Facing Layer | Polypropylene Spunbond | Polypropylene Spunbond | Spun-bond polypropylene | Same |
| Middle (Filter) Layer | Polypropylene Meltblown<br>Filter | Melt Blown Polypropylene<br>Filter | Melt blown polypropylene<br>filter | Same |
| Inner Facing Layer | Polypropylene Spunbond | Polyester Cellulose | Spun-bond polypropylene | Similar/Same |
| Nose Piece<br>(When Applicable) | PVC Coated Steel Wire | Malleable | Polypropylene + steel wire | Similar |
| Ear loops | White, Nylon/Spandex,<br>Latex Free | Polyester/Lycra Knitted | Nylon and Spandex;<br>elastic nonwoven fabrics<br>(spun-bond polypropylene<br>and elastic body) | Same |
| Color | Blue | Blue | Blue | Same |
| Dimension (Length) | 6.875" (+ 0.25", - 0.125") | 6.5" ± 0.75" | 175 ± 10mm | Same |
| Dimension (Width) | 3.75" (± 0.125") | 4" ± 0.75" | 95 ± 10mm | Same |
| OTC Use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use | Single Use, Disposable | Same |
| ASTM F2100 Level | Level 1 | Level 2 | Level 1 | Similar/Same |
| Performance Testing Comparison | | | | |
| Fluid Resistance<br>Performance ASTM<br>F1862 | 32 out of 32 passed at 80<br>mmHg,<br>3 lots | Meets Performance<br>Requirements at 120 mm<br>Hg | 32 out of 32 pass at 80<br>mmHg,<br>3 lots | All Meet<br>Requirements |
| Particulate Filtration<br>Efficiency ASTM<br>F2299 | 99.89%, 99.84%, 99.80% | 98.4% | 99.12%, 99.45%, 99.56% | All Meet<br>Requirements |
| Bacterial Filtration<br>Efficiency ASTM<br>F2101 | 99.80%, 99.71%, 99.81% | 99.7% | 99.92%, 99.93%, 99.92% | All Meet<br>Requirements |
| Differential Pressure<br>(Delta P) EN 14683<br>Annex C | 4.4 mmH2O/cm²,<br>4.7 mmH2O/cm²,<br>4.7 mmH2O/cm² | 4.50mmH2O/cm² | 3.0mmH2O/cm²,<br>4.2mmH2O/cm²,<br>3.7mmH2O/cm² | All Meet<br>Requirements |
| Flammability 16 CFR<br>1610 | Class 1 | Class 1 | Class 1 | All Meet<br>Requirements |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | All Meet<br>Requirements |
| Cytotoxicity | Under the conditions of the<br>study, the device is non-<br>cytotoxic | Non-Cytotoxic | Under the conditions of<br>the study, the device is<br>non-cytotoxic. | All Meet<br>Requirements |
| Irritation | Under the conditions of the<br>study, the device is non-<br>irritating* | Non-Irritating | Under the conditions of<br>the study, the device is<br>non-irritating. | All Meet<br>Requirements |
| Sensitization | Under the conditions of the<br>study, the device is non-<br>sensitizing* | Non-Sensitizing | Under the conditions of<br>the study, the device is<br>non-sensitizing | All Meet<br>Requirements |
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* Model GFM31A ASTM Level 1 mask uses the same materials as model GFM43A ASTM Level 3 mask. Since the Level 2 and Level 3 masks include one (1) additional layer of spunbond me "worst case" models for hiocompatibility testing and were subjected to all tests. The ASTM Level 1 mask was tested for Cytotoxicity only.
** Coloring in Spunbond occurs at the resin level and is a permanent part of the extructure. Color is not known to make a difference in performance.
#### Model GFM42A – ASTM Level 2
| | Proposed Device | Primary Predicate | Result | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------|
| Manufacturer | Little Rapids Corporation | Kimberly Clark<br>Corporation | - | |
| 510K Number | Not yet assigned | K111402 | - | |
| Product Common<br>Name(s) | Procedure Mask | Surgical Mask | Similar | |
| Model Number | GFM42A | KC200 | - | |
| Classification | Class II Device, FXX (21<br>CFR878.4040) | Class II Device, FXX (21<br>CFR878.4040) | Same | |
| Intended Use | The Procedure Masks are<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate | The Kimberly-Clark, K0200<br>and KC300 Face Mask(s) is<br>intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of | Same | |
| | material. These face masks<br>are intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device, provided<br>non-sterile. | microorganisms, body<br>fluids, particulate material.<br>These face masks are<br>intended for use in<br>infection control practices<br>to reduce the potential<br>exposure of the wearer to<br>blood and body fluids. The<br>KC200 and KC300 face<br>mask(s) is a single use,<br>disposable device(s),<br>provided non-sterile. | | |
| Design Features | Ear Loops, Flat Pleated, 4<br>layers | 4 Ply, Ear Loops, Flat-<br>Pleated or Tie-On Style | Same | |
| Materials & Design | | | | |
| Outer Facing Layer | Polypropylene Spunbond | Polypropylene Spunbond | Same | |
| Secondary Outer<br>Layer | Polypropylene Spunbond | Polypropylene Spunbond | Same | |
| Middle (Filter) Layer | Polypropylene Meltblown<br>Filter | Melt Blown Polypropylene<br>Filter | Same | |
| Inner Facing Layer | Polypropylene Spunbond | Polyester Cellulose | Similar | |
| Nose Piece | PVC Coated Steel Wire | Malleable | Similar | |
| Ear loops | White, Nylon/Spandex,<br>Latex Free | Polyester/Lycra Knitted | Same | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | 6.875" (+ 0.25", - 0.125") | 6.5" ± 0.75" | Same | |
| Dimension (Width) | 3.75" (± 0.125") | 4" ± 0.75" | Same | |
| OTC Use | Yes | Yes | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single Use, Disposable | Single Use | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Performance Testing Comparison | | | | |
| | | | | |
| Fluid Resistance<br>Performance ASTM<br>F1862 | 32 out of 32 passed at 160 mm Hg, 3 lots | Meets Performance<br>Requirements at 120 mm Hg | Both Meet<br>Requirements | |
| Particulate Filtration<br>Efficiency ASTM<br>F2299 | 99.84%, 99.85%, 99.87% | 98.4% | Both Meet<br>Requirements | |
| Bacterial Filtration<br>Efficiency ASTM<br>F2101 | 99.8%, 99.7%, 99.7% | 99.7% | Both Meet<br>Requirements | |
| Differential Pressure<br>(Delta P) EN 14683<br>Annex C | 4.7 mmH2O/cm²,<br>5.0 mmH2O/cm²,<br>5.0 mmH2O/cm² | 4.50mmH2O/cm² | Both Meet<br>Requirements | |
| Flammability 16 CFR<br>1610 | Class 1 | Class 1 | Both Meet<br>Requirements | |
| Biocompatibility | ISO 10993 | ISO 10993 | Both Meet<br>Requirements | |
| Cytotoxicity | Under the conditions of the<br>study, the device is non-cytotoxic | Non-Cytotoxic | Both Meet<br>Requirements | |
| Irritation | Under the conditions of the<br>study, the device is non-irritating* | Non-Irritating | Both Meet<br>Requirements | |
| Sensitization | Under the conditions…
