Nitrile Powder Free Examination Gloves Biodegradable (Green)
Device Facts
| Record ID | K240269 |
|---|---|
| Device Name | Nitrile Powder Free Examination Gloves Biodegradable (Green) |
| Applicant | Comfort Rubber Gloves Industries Sdn. Bhd. |
| Product Code | LZA · General Hospital |
| Decision Date | Oct 25, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Device Story
Disposable, non-sterile nitrile examination glove; worn on examiner's hand or finger; acts as physical barrier to prevent contamination between examiner and patient. Used in clinical settings; operated by healthcare professionals. Device provides protection during patient examinations; reduces risk of cross-contamination. Biodegradable material composition.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM D6319-19 (physical properties, dimensions), ASTM D5151-19 (watertightness), ASTM D6124-06 (residual powder), ASTM D5511-18 (biodegradation), and ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity).
Technological Characteristics
Material: Nitrile. Form factor: Disposable, non-sterile, powder-free glove. Sizes: S, M, L, XL, XXL. Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D5511-18, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-11. Shelf life: 3 years (accelerated).
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between examiner and patient. No specific age or gender restrictions; intended for general clinical use.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Biodegradable Nitrile Examination Powder Free Glove, Green (K192111)
Related Devices
- K202086 — Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors · Shen Wei USA, Inc. · Mar 16, 2021
- K990577 — TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES · Ta Chia Rubber Ind. Corp. · May 4, 1999
- K110185 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES · Tangshan Baojie Glove Co., Ltd. · Apr 4, 2011
- K103770 — SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL · Syntex Healthcare Products Co., Ltd. · Apr 21, 2011
- K202081 — Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue · Shen Wei USA, Inc. · Mar 19, 2021
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2024
Comfort Rubber Gloves Industries Sdn. Bhd. Sumanthi D/O Saravana Sami RA Manager Lot 821 Matang, Perak 34750 Malaysia
Re: K240269
Trade/Device Name: Nitrile Powder Free Examination Gloves Biodegradable (Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 2, 2024 Received: September 30, 2024
Dear Sumanthi D/O Saravana Sami:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Bifeng Qian -S" in a large, sans-serif font. The text is black and stands out against a white background. The name appears to be a person's name, with "Bifeng" as the first name and "Qian" as the last name. The "-S" at the end could be an initial or a designation.
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control 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
Submission Number (if known)
K240269
Device Name
Nitrile Powder Free Examination Gloves Biodegradable (Green)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
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 (K240269) Nitrile Powder Free Examination Gloves Biodegradable (Green)
#### 1.0 Submitter:
| Name | : Comfort Rubber Gloves Industries Sdn. Bhd |
|-----------------|-------------------------------------------------------------------------|
| Address | : Lot 821, Jalan Matang,<br>34750 Matang, Perak, Malaysia.<br>Malaysia. |
| Phone No. | : 605-847 2777 |
| Fax No. | : 605-847 9108 |
| Contact Person: | : Sumathi d/o Sararavan Sami (Miss.) |
Date of Preparation: January 8, 2024
#### 2.0 Name of the Device
Nitrile Powder Free Examination Gloves Biodegradable (Green)
Common Name: Patient Examination Gloves
Classification Name: Non-powdered Patient Examination Gloves (21 CFR 880.6250 product code LZA)
#### 3.0 Predicate Device
Device Name: Biodegradable Nitrile Examination Powder Free Glove, Green Company: Top Glove SDN BHD
510(K) No.: K192111
#### 4.0 Description of the Device:
Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.
#### 5.0 Indication for Use of the Device
The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
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Image /page/5/Picture/1 description: The image shows a green nitrile powder-free examination glove. The glove is biodegradable and is laid flat on a white surface. The text at the top of the image indicates the type of glove, and the text at the bottom indicates that it is page 1 of 1.
### 6.0 Photo and/or figure of Nitrile Powder Free Examination Gloves Biodegradable (Green)
### 7.0 Technological Characteristics Comparison Table:
| CHARACTERISTICS | STANDARDS | PREDICATE DEVICE<br>K192111 | SUBJECT DEVICE<br>K240269 | COMPARISON | EXPLANATION |
|-----------------|-----------|-----------------------------|---------------------------|------------|-------------|
| Product Code | | LZA | LZA | Same | |
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| Device Name | | Biodegradable Nitrile<br>Examination Powder<br>Free Glove, Green | Nitrile Powder Free<br>Examination Gloves<br>Biodegradable<br>(Green) | Similar | Device names are<br>different, but both<br>serve the same<br>intended use as<br>examination gloves. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer(s) | | Top Gloves Sdn. Bhd. | Comfort Rubber<br>Gloves Industries<br>Sdn. Bhd | Different | Difference in<br>manufacturers.<br>Manufacturers<br>adhere to industry<br>standards and<br>regulations,<br>ensuring that their<br>products are<br>equally safe and<br>effective |
| Indication for Use | | The Biodegradable<br>Nitrile Examination<br>Powder Free Glove,<br>Green is a non-sterile<br>disposable device<br>intended for medical<br>purpose that is worn<br>on examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | The Nitrile Powder<br>Free Examination<br>Gloves<br>Biodegradable<br>(Green) is a medical<br>glove which is a<br>disposable device<br>intended for medical<br>purposes that is<br>worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between examiner<br>and patient. | Similar | The indications are<br>comparable,<br>indicating that both<br>products serve the<br>same function and<br>intended use within<br>clinical settings.<br>This similarity<br>reinforces the claim<br>of substantial<br>equivalence, as<br>both products are<br>designed to meet<br>the same clinical<br>needs and safety<br>standards |
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same | - |
| Color | | Green | Green | Same | - |
| Size | Medical Glove<br>Guidance Manual<br>Labeling | Small | Small | - | - |
| | | Medium | Medium | Same | - |
| | | Large | Large | | |
| | | Extra Large | Extra Large | | |
| | | Double Extra Large | Double Extra Large | | |
| Single Use | Medical Glove<br>Guidance Manual | Single Use | Single Use | Same | - |
| Shelf life | Medical Glove<br>Guidance Manual | - | Accelerated 3 Years | Different | Does not impact<br>substantial<br>equivalence<br>because the shelf<br>life is determined by<br>specific stability<br>testing conducted<br>under relevant<br>conditions |
| Sterile | Medical Glove<br>Guidance Manual | Non-Sterile | Non-Sterile | Same | - |
| Dimension | ASTM D6319- 19 | Length-Min 230mm<br>Thickness palm and<br>finger- Min 0.05mm | Length-Min 230mm<br>Thickness palm and<br>finger-Min 0.05mm<br>Width -<br>S - 80±10mm<br>M - 95±10mm<br>L - 105 ± 5mm<br>XL - 115 ± 5mm<br>XXL -> 120 mm | Similar | Slight variation in<br>length (240 mm vs.<br>230 mm) does not<br>impact usability or<br>safety, as both<br>dimensions fall<br>within acceptable<br>ranges for<br>examination gloves |
| Physical Properties | ASTM D6319- 19 | Before Aging | | Similar | - |
| | | Tensile Strength<br>≥14MPa<br>Ultimate<br>Elongation≥500% | Tensile Strength<br>≥14MPa<br>Ultimate<br>Elongation≥500% | | |
| | | After Aging | | | The test result<br>reading might have<br>variance but meets<br>the ASTM D6319<br>requirement. |
| | | Tensile Strength<br>≥14MPa<br>Ultimate<br>Elongation≥400% | Tensile Strength<br>≥14MPa<br>Ultimate<br>Elongation≥400% | | |
| Thickness - Finger<br>– Palm | ASTM D6319-19 | Min 0.05<br>Min 0.05 | 0.16 mm - 0.20 mm<br>0.12 mm - 0.14 mm | Similar | The test result<br>reading might have<br>variance but meets<br>the ASTM D6319<br>requirement. |
| Residual Powder | ASTM 6124-06 -2022 | Max - 2 mg/glove | Max - 2 mg/glove<br>0.36 mg/glove | Same | |
| Biodegradable | ASTM D5511 | Tested | Tested | Similar | The test result<br>reading might have<br>variance but meets<br>the ASTM D5511<br>requirement. |
| | ISO 10993-23:2021<br>Biological evaluation<br>of medical devices<br>Part 23:Tests for<br>irritation | Under the conditions<br>of the study, the<br>subject device extracts<br>are not irritating to the<br>animal model. | Under the conditions<br>of the study, the<br>subject device is<br>non-irritating<br>extracts are not<br>irritating to the<br>animal model. | Same | -- |
| Biocompatibility | ISO 10993- 10:2021<br>Biological evaluation<br>of medical devices<br>Part 10: Tests for<br>skin sensitization | Under the conditions<br>of the study, the<br>subject device extracts<br>are not sensitizing to<br>the animal model. | Under the conditions<br>of the study, the<br>subject device<br>extracts are not<br>sensitizing to the<br>animal model. | Same | -- |
| | Cytotoxicity ISO<br>10993-5:2009 -<br>Biological evaluation<br>of medical devices --<br>Part 5: Tests for in<br>vitro cytotoxicity | Under the conditions<br>of the study, the<br>subject device extract<br>exhibits mild<br>cytotoxicity reactivity<br>result (2) with the neat<br>extract (100%). | Under the conditions<br>of the study, the<br>subject device<br>extract exhibits mild<br>cytotoxicity reactivity<br>result (2) with the<br>neat extract (100%). | Same | -- |
| | ISO 10993-11:2017<br>Biological evaluation<br>of medical devices<br>Part 11: Tests for<br>systemic toxicity | No test report was<br>submitted for the<br>predicate. | Under the conditions<br>of the study, did not<br>demonstrate any<br>acute toxic reaction. | Different | The Acute systemic<br>toxicity is additional<br>test tested to<br>evaluate the<br>potential for<br>systemic health<br>effects resulting<br>from exposure to<br>the materials used<br>in the gloves. |
| Watertight (1000ml) | 21 CFR 800.20<br>ASTM D5151 | Passes | Passes | Same | -- |
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### Summary of Non-Clinical Performance Data 8.0
| Test Methodology | Purpose | Acceptance Criteria | Results | | | | | | | | | | | | | | | | | | |
|---------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application | To determine the<br>length of the gloves | Min 230 for all sizes | Average:<br>S – 246<br>M – 246<br>L – 246<br>XL - 250<br>XXL - 254 | | | | | | | | | | | | | | | | | | |
| | To determine the width<br>of the gloves | S – 80±10mm<br>M – 95±10mm<br>L – 105 ± 5mm<br>XL - 115 ± 5mm<br>XXL - > 120 mm | Average:<br>S – 86<br>M – 99<br>L – 106<br>XL - 115<br>XXL - 125 | | | | | | | | | | | | | | | | | | |
| | To determine the<br>thickness of the gloves | Thickness palm and<br>finger- Min 0.05mm | Average:<br>Size Palm Finger S 0.13 0.19 M 0.13 0.19 L 0.13 0.18 XL 0.13 0.17 XXL 0.12 0.19 | | | | | | | | | | | | | | | | | | |
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| Test Methodology | Purpose | Acceptance Criteria | Results | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| ASTM D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application | To determine the<br>Physical properties –<br>Tensile Strength | Before Aging – Min 14<br>MPa<br>After Aging - Min 14<br>MPa | Size | Before<br>Aging | After<br>Aging |
| | | | M | 29.95 | 29.66 |
| | To determine the<br>Physical properties -<br>Ultimate Elongation | Before Aging -<br>Min.500<br>After Aging - Min. 400 | Size | Before<br>Aging | After<br>Aging |
| | | | M | 561 | 496 |
| ASTM D5151-19<br>Standard Test Method<br>for Detection of Holes<br>in Medical Gloves | To determine the holes<br>in the gloves | AQL 1.5 | | S – Pass AQL 1.5 | |
| | | | | M – Pass AQL 1.5 | |
| | | | | L – Pass AQL 1.5 | |
| | | | | XL – Pass AQL 1.5 | |
| | | | | XXL – Pass AQL 1.5 | |
| ASTM D6124-06(2022)<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>amount of residual<br>powder on the gloves | Max - 2 mg/glove | | 0.36mg | |
| ASTM D5511-18<br>Standard Test Method<br>for Determining<br>Anaerobic<br>Biodegradation of<br>Plastic Materials<br>Under High-Solids<br>Anaerobic-Digestion<br>Condition | Determination of the<br>degree and rate of<br>anaerobic<br>biodegradation of<br>plastic materials in<br>high-solids anaerobic<br>conditions | Tested | | Adjusted Percent<br>Biodegraded (%) – 7.2 | |
| ISO 10993-5<br>Biological evaluation<br>of medical devices-<br>Part 5 Tests for in<br>vitro cytotoxicity | To determine the<br>biological response of<br>mammalian cells in<br>vitro using appropriate<br>biological parameters | - | | Under the conditions of<br>the study, the subject<br>device extract exhibits<br>mild cytotoxicity<br>reactivity result (2) with<br>the neat extract (100%). | |
| ISO 10993-10:2021<br>Biological evaluation<br>of medical devices<br>Part 10: Tests for<br>skin sensitization | Assessment of medical<br>devices and their<br>constituent materials<br>with regard to their<br>potential to induce skin<br>sensitization | - | | Under the conditions of<br>the study, the subject<br>device extracts are not<br>sensitizing to the animal<br>model. | |
| ISO 10993-23:2021<br>Biological evaluation<br>of medical devices<br>Part 23: Tests for<br>irritation | Assessment of medical<br>devices and their<br>constituent materials<br>with regard to their<br>potential to produce<br>irritation | - | | Under the conditions of<br>the study, the subject<br>device is non-irritating<br>extracts are not irritating<br>to the animal model. | |
| ISO 10993-11:2017<br>Biological evaluation<br>of medical devices<br>Part 11: Tests for<br>systemic toxicity | Evaluation of the<br>potential for medical<br>device materials to<br>cause adverse<br>systemic reactions | - | | Under the conditions of<br>the study, did not<br>demonstrate any<br>acute toxic reaction. | |
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Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- . ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D5511-18 Standard Test Method for Determining Anaerobic Biodegradation of Plastic . Materials Under High-Solids Anaerobic-Digestion Condition
- . ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
- . ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity
- . ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation ●
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity .
### 9.0 Clinical Performance Data
Clinical data is not needed.
#### 10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
