(134 days)
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.
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.
The provided document contains information on the acceptance criteria and performance testing for a medical device (Procedure Mask). However, it does not include information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML or diagnostic devices, such as:
- Sample size for a test set (it mentions testing on "three non-consecutive production lots" for the ASTM performance tests, which refers to the mask itself, not a dataset for an AI model).
- Data provenance for the test set.
- Number of experts or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Effect size of human readers improving with AI assistance.
- Standalone performance (for an AI algorithm).
- Type of ground truth (beyond the mask's physical performance).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is for a Procedure Mask, a physical medical device, not an AI/ML-driven diagnostic or image analysis device. Therefore, the questions related to AI/ML study design are not applicable to the information contained in this document.
The acceptance criteria here pertain to the physical and functional performance of the mask as per relevant ASTM and ISO standards for medical face mask materials and biocompatibility.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM F2100 levels (Level 1, Level 2, Level 3) which define performance requirements for medical face masks. The tables within the document compare the proposed device's performance to the predicate device's performance against these standards.
Model GFM31A (ASTM Level 1)
| Performance Test | Acceptance Criteria (from ASTM F2100 Level 1) | Reported Device Performance (GFM31A) | Reported Predicate Performance (KC200/Y01) | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥ 80 mmHg | 32 out of 32 passed at 80 mmHg (3 lots) | Meets Performance Requirements at 120 mm Hg (KC200); 32 out of 32 pass at 80 mmHg (Y01) | All Meet Requirements |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 95% | 99.89%, 99.84%, 99.80% | 98.4% (KC200); 99.12%, 99.45%, 99.56% (Y01) | All Meet Requirements |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 95% | 99.80%, 99.71%, 99.81% | 99.7% (KC200); 99.92%, 99.93%, 99.92% (Y01) | All Meet Requirements |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 5.0 mmH2O/cm² | 4.4 mmH2O/cm², 4.7 mmH2O/cm², 4.7 mmH2O/cm² | 4.50mmH2O/cm² (KC200); 3.0mmH2O/cm², 4.2mmH2O/cm², 3.7mmH2O/cm² (Y01) | All Meet Requirements |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 | All Meet Requirements |
| Biocompatibility (ISO 10993) | Non-cytotoxic | Non-cytotoxic (GFM31A was tested for Cytotoxicity only, as per note) | Non-Cytotoxic | All Meet Requirements |
| Non-irritating | Non-irritating* | Non-Irritating | All Meet Requirements | |
| Non-sensitizing | Non-sensitizing* | Non-Sensitizing | All Meet Requirements |
*GFM31A uses the same materials as GFM43A, and GFM43A (a Level 3 mask) was subjected to all biocompatibility tests as the "worst case" model. GFM31A was specifically tested for cytotoxicity only.
Model GFM42A (ASTM Level 2)
| Performance Test | Acceptance Criteria (from ASTM F2100 Level 2) | Reported Device Performance (GFM42A) | Reported Predicate Performance (KC200) | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥ 120 mmHg | 32 out of 32 passed at 160 mm Hg (3 lots) | Meets Performance Requirements at 120 mm Hg | Both Meet Requirements |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 95% | 99.84%, 99.85%, 99.87% | 98.4% | Both Meet Requirements |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 95% | 99.8%, 99.7%, 99.7% | 99.7% | Both Meet Requirements |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 5.0 mmH2O/cm² | 4.7 mmH2O/cm², 5.0 mmH2O/cm², 5.0 mmH2O/cm² | 4.50mmH2O/cm² | Both Meet Requirements |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 | Both Meet Requirements |
| Biocompatibility (ISO 10993) | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating*, Non-sensitizing* | Non-Cytotoxic, Non-Irritating, Non-Sensitizing | Both Meet Requirements |
*GFM42A uses identical materials to GFM43A, which was used for irritation and sensitization testing as a "worst case" model due to an additional layer of material.
Model GFM43A (ASTM Level 3)
| Performance Test | Acceptance Criteria (from ASTM F2100 Level 3) | Reported Device Performance (GFM43A) | Reported Predicate Performance (KC300) | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥ 160 mmHg | 32 out of 32 passed at 160 mm Hg (3 lots) | Meets Performance Requirements at 160 mm Hg | All Meet Requirements |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.84%, 99.85%, 99.87% | 98.4% | All Meet Requirements |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.8%, 99.7%, 99.7% | 99.7% | All Meet Requirements |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH2O/cm² | 4.7 mmH2O/cm², 5.0 mmH2O/cm², 5.0 mmH2O/cm² | 3.20mmH2O/cm² | All Meet Requirements |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 | All Meet Requirements |
| Biocompatibility (ISO 10993) | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing | All Meet Requirements |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the ASTM performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure), the tests were conducted "in triplicate on samples obtained from three non-consecutive production lots." For Fluid Resistance (ASTM F1862), it states "32 out of 32 passed at X mmHg, 3 lots," implying a sample size of 32 per lot for that specific test.
- Data Provenance: Not specified, but generally, such tests are conducted by certified laboratories as per industry standards. No information regarding country of origin or retrospective/prospective nature is given, as it's not relevant for a physical product's performance testing in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical product's performance testing based on established standards (ASTM, EN, ISO). Ground truth is the defined standard performance, not expert opinion.
4. Adjudication method for the test set:
- Not applicable. Performance is measured directly against predefined quantitative standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The ground truth is based on established industry standards and physical measurements. For example, for fluid resistance, the standard specifies a certain pressure; for filtration efficiency, it specifies a minimum percentage. For biocompatibility, it's defined by the absence of cytotoxicity, irritation, and sensitization as per ISO 10993.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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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
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 ClarkCorporation | U-Play ProductsCorporation | - |
| 510K Number | K220377 | K111402 | K202137 | - |
| Product CommonName(s) | Procedure Mask | Surgical Mask | Disposable Medical Mask | Similar |
| Model Number | GFM31A | KC200 | Y01 | - |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same |
| Intended Use | The Procedure Masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood and bodyfluids. Both models aresingle use, disposabledevices, provided non-sterile. | The Kimberly-Clark, K0200and KC300 Face Mask(s) isintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids, particulate material.These face masks areintended for use ininfection control practicesto reduce the potentialexposure of the wearer toblood and body fluids. TheKC200 and KC300 facemask(s) is a single use,disposable device(s),provided non-sterile. | The Disposable MedicalMasks are intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is a singleuse, disposable device(s),provided non-sterile. | Same |
| Design Features | Ear Loops, Flat Pleated, 3layers, Nose Piece or NoNose Piece | 4 Ply, Ear Loops, Flat-Pleated or Tie-On Style | Ear Loops, Flat Pleated, 3layers | Similar |
| Materials & Design | ||||
| Outer Facing Layer | Polypropylene Spunbond | Polypropylene Spunbond | Spun-bond polypropylene | Same |
| Middle (Filter) Layer | Polypropylene MeltblownFilter | Melt Blown PolypropyleneFilter | Melt blown polypropylenefilter | Same |
| Inner Facing Layer | Polypropylene Spunbond | Polyester Cellulose | Spun-bond polypropylene | Similar/Same |
| Nose Piece(When Applicable) | PVC Coated Steel Wire | Malleable | Polypropylene + steel wire | Similar |
| Ear loops | White, Nylon/Spandex,Latex Free | Polyester/Lycra Knitted | Nylon and Spandex;elastic nonwoven fabrics(spun-bond polypropyleneand 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 ResistancePerformance ASTMF1862 | 32 out of 32 passed at 80mmHg,3 lots | Meets PerformanceRequirements at 120 mmHg | 32 out of 32 pass at 80mmHg,3 lots | All MeetRequirements |
| Particulate FiltrationEfficiency ASTMF2299 | 99.89%, 99.84%, 99.80% | 98.4% | 99.12%, 99.45%, 99.56% | All MeetRequirements |
| Bacterial FiltrationEfficiency ASTMF2101 | 99.80%, 99.71%, 99.81% | 99.7% | 99.92%, 99.93%, 99.92% | All MeetRequirements |
| Differential Pressure(Delta P) EN 14683Annex C | 4.4 mmH2O/cm²,4.7 mmH2O/cm²,4.7 mmH2O/cm² | 4.50mmH2O/cm² | 3.0mmH2O/cm²,4.2mmH2O/cm²,3.7mmH2O/cm² | All MeetRequirements |
| Flammability 16 CFR1610 | Class 1 | Class 1 | Class 1 | All MeetRequirements |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | All MeetRequirements |
| Cytotoxicity | Under the conditions of thestudy, the device is non-cytotoxic | Non-Cytotoxic | Under the conditions ofthe study, the device isnon-cytotoxic. | All MeetRequirements |
| Irritation | Under the conditions of thestudy, the device is non-irritating* | Non-Irritating | Under the conditions ofthe study, the device isnon-irritating. | All MeetRequirements |
| Sensitization | Under the conditions of thestudy, the device is non-sensitizing* | Non-Sensitizing | Under the conditions ofthe study, the device isnon-sensitizing | All MeetRequirements |
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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 ClarkCorporation | - | |
| 510K Number | Not yet assigned | K111402 | - | |
| Product CommonName(s) | Procedure Mask | Surgical Mask | Similar | |
| Model Number | GFM42A | KC200 | - | |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same | |
| Intended Use | The Procedure Masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulate | The Kimberly-Clark, K0200and KC300 Face Mask(s) isintended to be worn toprotect both the patientand healthcare personnelfrom transfer of | Same | |
| material. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device, providednon-sterile. | microorganisms, bodyfluids, particulate material.These face masks areintended for use ininfection control practicesto reduce the potentialexposure of the wearer toblood and body fluids. TheKC200 and KC300 facemask(s) is a single use,disposable device(s),provided non-sterile. | |||
| Design Features | Ear Loops, Flat Pleated, 4layers | 4 Ply, Ear Loops, Flat-Pleated or Tie-On Style | Same | |
| Materials & Design | ||||
| Outer Facing Layer | Polypropylene Spunbond | Polypropylene Spunbond | Same | |
| Secondary OuterLayer | Polypropylene Spunbond | Polypropylene Spunbond | Same | |
| Middle (Filter) Layer | Polypropylene MeltblownFilter | Melt Blown PolypropyleneFilter | Same | |
| Inner Facing Layer | Polypropylene Spunbond | Polyester Cellulose | Similar | |
| Nose Piece | PVC Coated Steel Wire | Malleable | Similar | |
| Ear loops | White, Nylon/Spandex,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 ResistancePerformance ASTMF1862 | 32 out of 32 passed at 160 mm Hg, 3 lots | Meets PerformanceRequirements at 120 mm Hg | Both MeetRequirements | |
| Particulate FiltrationEfficiency ASTMF2299 | 99.84%, 99.85%, 99.87% | 98.4% | Both MeetRequirements | |
| Bacterial FiltrationEfficiency ASTMF2101 | 99.8%, 99.7%, 99.7% | 99.7% | Both MeetRequirements | |
| Differential Pressure(Delta P) EN 14683Annex C | 4.7 mmH2O/cm²,5.0 mmH2O/cm²,5.0 mmH2O/cm² | 4.50mmH2O/cm² | Both MeetRequirements | |
| Flammability 16 CFR1610 | Class 1 | Class 1 | Both MeetRequirements | |
| Biocompatibility | ISO 10993 | ISO 10993 | Both MeetRequirements | |
| Cytotoxicity | Under the conditions of thestudy, the device is non-cytotoxic | Non-Cytotoxic | Both MeetRequirements | |
| Irritation | Under the conditions of thestudy, the device is non-irritating* | Non-Irritating | Both MeetRequirements | |
| Sensitization | Under the conditions of thestudy, the device is non-sensitizing* | Non-Sensitizing | Both MeetRequirements | |
| Device | Proposed Device | Primary Predicate | Additional Predicate | Result |
| Manufacturer | Little Rapids Corporation | Kimberly Clark | Kimberly Clark | - |
| Corporation | Corporation | |||
| 510K Number | Not yet assigned | K111402 | K111402 | - |
| Product Common | Procedure Mask | Surgical Mask | Surgical Mask | Similar |
| Name(s) | ||||
| Model Number | GFM43A | KC200 | KC300 | |
| Classification | Class II Device, FXX (21 | Class II Device, FXX (21 | Class II Device, FXX (21 | Same |
| CFR878.4040) | CFR878.4040) | CFR878.4040) | ||
| Intended Use | The Procedure Masks are | The Kimberly-Clark, K0200 | The Kimberly-Clark, KC200 | Same |
| intended to be worn to | and KC300 Face Mask(s) is | and KC300 Face Mask(s) is | ||
| protect both the patient and | intended to be worn to | intended to be worn to | ||
| healthcare personnel from | protect both the patient | protect both the patient | ||
| transfer of microorganisms, | and healthcare personnel | and healthcare personnel | ||
| body fluids, and particulate | from transfer of | from transfer of | ||
| material. These face masks | microorganisms, body | microorganisms, body | ||
| are intended for use in | fluids, particulate material. | fluids, particulate material. | ||
| infection control practices | These face masks are | These face masks are | ||
| to reduce the potential | intended for use in | intended for use in | ||
| exposure to blood and body | infection control practices | infection control practices | ||
| fluids. This is a single use, | to reduce the potential | to reduce the potential | ||
| disposable device, provided | exposure of the wearer to | exposure of the wearer to | ||
| non-sterile. | blood and body fluids. The | blood and body fluids. The | ||
| KC200 and KC300 face | KC200 and KC300 face | |||
| mask(s) is a single use, | mask(s) is a single use, | |||
| disposable device(s), | disposable device(s), | |||
| provided non-sterile. | provided non-sterile. | |||
| Design Features | Ear Loops, Flat Pleated, 4 | 4 Ply, Ear Loops, Flat- | 4 Ply, Ear Loops, Flat- | Same |
| layers | Pleated or Tie-On Style | Pleated or Tie-On Style | ||
| Materials & Design | ||||
| Outer Facing Layer | Polypropylene Spunbond | Polypropylene Spunbond | Polypropylene Spunbond | Same |
| Secondary OuterLayer | Polypropylene Spunbond | Polypropylene Spunbond | Polypropylene Spunbond | Same |
| Middle (Filter) Layer | Polypropylene MeltblownFilter | Melt Blown PolypropyleneFilter | Melt Blown PolypropyleneFilter | Same |
| Inner Facing Layer | Spun-bond polypropylene | Polyester Cellulose | Polyester Cellulose | Same |
| Nose Piece | PVC Coated Steel Wire | Malleable | Malleable | Similar |
| Ear loops | White, Nylon/Spandex,Latex Free | Polyester/Lycra Knitted | Polyester/Lycra Knitted | Same |
| Color | Blue | Blue | Orange | Same/Different** |
| Dimension (Length) | 6.875" (+ 0.25", - 0.125") | 6.5" ± 0.75" | 6.5" ± 0.75" | Same |
| Dimension (Width) | 3.75" (± 0.125") | 4" ± 0.75" | 4" ± 0.75" | Same |
| OTC Use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use | Single Use | Same |
| ASTM F2100 Level | Level 3 | Level 2 | Level 3 | Same |
| Performance Testing Comparison | ||||
| Fluid ResistancePerformance ASTMF1862 | 32 out of 32 passed at 160 mm Hg, 3 lots | Meets PerformanceRequirements at 120 mmHg | Meets PerformanceRequirements at 160 mmHg | All MeetRequirements |
| Particulate FiltrationEfficiency ASTMF2299 | 99.84%, 99.85%, 99.87% | 98.4% | 98.4% | All MeetRequirements |
| Bacterial FiltrationEfficiency ASTMF2101 | 99.8%, 99.7%, 99.7% | 99.7% | 99.7% | All MeetRequirements |
| Differential Pressure(Delta P) EN 14683Annex C | 4.7 mmH2O/cm²,5.0 mmH2O/cm²,5.0 mmH2O/cm² | 4.50mmH2O/cm² | 3.20mmH2O/cm² | All MeetRequirements |
| Flammability 16 CFR1610 | Class 1 | Class 1 | Class 1 | All MeetRequirements |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | All MeetRequirements |
| Cytotoxicity | Under the conditions of thestudy, the device is non-cytotoxic | Non-Cytotoxic | Non-cytotoxic | All MeetRequirements |
| Irritation | Non-Irritating | Non-irritating | ||
| Sensitization | Non-Sensitizing | Non-sensitizing |
{9}------------------------------------------------
{10}------------------------------------------------
- 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 material, these masks are considered the "worst case" models for bioced 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.
{11}------------------------------------------------
GFM43A – ASTM Level 3
{12}------------------------------------------------
{13}------------------------------------------------
- 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 the "worst case" models for biocompatibility testing and were subjected to all tests. The ASTM Level 1 mask was tested for Cytotoxicity only.
** Coloring in Spunbord occurs at the resin level and it the extruded fiber structure. Color is not known to make a difference in performance.
{14}------------------------------------------------
K220377 Page 12of 12
I. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as the same or similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
- A ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at A Known Velocity)
- A EN 14683, Medical Face Masks-Requirements and Test Methods
- A ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus
- A ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres
- A 16 CFR 1610, Standard for the Flammability of clothing textiles
Note – The ASTM (performance) tests noted above were conducted in triplicate on samples obtained from three non-consecutive production lots.
J. Clinical Test Conclusion
No clinical study is included in this submission.
K. Conclusion
Based on the nonclinical tests performed, the subject devices are as safe, as effective, and perform as well as the legally marketed primary predicate device Kimberly Clark Corporation KC200 cleared under K111402, and additional predicate devices U-Play Products Corporation Y01 cleared under K202137 and Kimberly Clark Corporation KC300 cleared under K111402.
§ 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.