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Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential

Q: Who is the manufacturer of Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential?

Comfort Rubber Gloves Industries Sdn. Bhd. filed the 510(k) submission for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528).

Q: What is the FDA product code for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

Q: What is the regulatory pathway for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential?

510(k) clearance (submission type: Traditional).

K241528 · Comfort Rubber Gloves Industries Sdn. Bhd. · LZA · Aug 6, 2024 · General Hospital

Device Facts

Record ID	K241528
Device Name	Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
Applicant	Comfort Rubber Gloves Industries Sdn. Bhd.
Product Code	LZA · General Hospital
Decision Date	Aug 6, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

Intended Use

The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential 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 nitrile examination glove; worn by healthcare examiners to provide barrier protection against contamination between examiner and patient. Device is non-sterile and blue in color. Manufactured to meet ASTM D6319-19 standards for physical dimensions, tensile strength, and elongation. Low dermatitis potential verified via Modified Draize ASTM 6355-07 testing. Used in clinical settings; operated by healthcare professionals. Provides physical barrier to reduce cross-contamination risk.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-19 (dimensions, physical properties), ASTM D6124-06 (powder residue), and ASTM D5151-19 (freedom from holes). Biocompatibility testing performed per ISO 10993 series: ISO 10993-23 (irritation), ISO 10993-10 (sensitization), ISO 10993-5 (cytotoxicity), and ISO 10993-11 (acute systemic toxicity). Low dermatitis potential confirmed via Modified Draize ASTM 6355-07.

Technological Characteristics

Nitrile material; powder-free. Dimensions and physical properties meet ASTM D6319-19. Biocompatibility testing per ISO 10993-5, 10, 11, 23. Low dermatitis potential per ASTM 6355-07. Non-sterile. Sizes XS, S, M, L, XL.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between examiner and patient.

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

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K162646)

Related Devices

K052382 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE · Pt.Shamrock Manufacturing Corp. · Sep 15, 2005
K103337 — MULTIPLE NAME · Ideal Quality Sdn., Bhd. · Feb 25, 2011
K213678 — Powder Free Blue Nitrile Examination Gloves · Lienteh Technology Sdn Bhd · Mar 22, 2022
K081911 — NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE · Siam Sempermed Corp., Ltd. · Jan 15, 2009
K120970 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) · Tangshan Zhonghong Pulin Plastic Co.,Ltd · Jul 19, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. August 8, 2024 Comfort Rubber Gloves Industries Sdn. Bhd. % Terrell Cunningham Regulatory Consultant T. Cunningham Consulting & Associates, LLC 12812 Meadowbrook LN Waldorf, Maryland 20601 Re: K241528 Trade/Device Name: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dear Terrell Cunningham: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 6, 2024. Specifically, FDA is updating this SE Letter to correct a typo in the Regulatory Class as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, M.D., Ph.D., OHT4: Office of Surgical and Infection Control Devices, at Bifeng. Qian@fda.hhs.gov. Sincerely, Bifeng Qian -S 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". August 6, 2024 Comfort Rubber Gloves Industries Sdn. Bhd. % Terrell Cunningham Regulatory Consultant T. Cunningham Consulting & Associates, LLC 12812 Meadowbrook LN Waldorf, Maryland 20601 Re: K241528 Trade/Device Name: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class II Product Code: LZA Dated: April 2, 2024 Received: May 30, 2024 Dear Terrell Cunningham: 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/cdrb/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. {2}------------------------------------------------ Additional information about changes that may requre 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" (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 (OS) 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 QS regulation requires device manufacturers to review and approve changes to device design and production (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. 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). {3}------------------------------------------------ Sincerely, # Allan Guan -S For 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 {4}------------------------------------------------ # Indications for Use Submission Number (if known) K241528 Device Name Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Indications for Use (Describe) The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ ## 510(k) SUMMARY- K241528 ### Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential #### 1.0 Submitter: | Name | Comfort Rubber Gloves Industries Sdn. Bhd. | |-----------------|-----------------------------------------------------------------------| | Address | Lot 821, Jalan Matang, 34750 Matang, Perak, Malaysia. Malaysia. | | Phone No. | 605-847 2777 | | Fax No. | 605-847 9108 | | Contact Person: | Sumathi d/o Sararavan Sami (Miss.) | Date of Preparation: 1st August 2024 #### 2.0 Name of the Device Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250) Class: I Product Code: LZA #### 3.0 Predicate Device Device Name: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) Company: Hartalega SDN. BHD 510(k) No.: K162646 Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250) Class: I Product Code: LZA #### 4.0 Description of the Device: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. {6}------------------------------------------------ #### 5.0 Indication for Use of the Device The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential 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. #### 6.0 Summary of the Technological Characteristics of the Device: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential and predicate, K162646 are summarized with the following technological characteristics. Both gloves are made with nitrile and meets ASTM D6319-19 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards. | CHARACTERISTIC | PREDICATE DEVICE K162646 | SUBJECT DEVICE K241528 | COMPARISON | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer(s) | Hartalega SDN. BHD | Comfort Rubber Gloves Industries Sdn. Bhd | Different | | Device Name | Nitrile Powder Free Examination Glove, Non- Sterile Low Dermatitis Potential (Blue) | Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential | Similar | | Indications for Use | The Nitrile Powder Free Examination Glove, Non- Sterile Low Dermatitis (Blue) Potential 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. | The Nitrile Powder Free Examination Gloves (Blue), Non- Sterile Low Dermatitis Potential 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. | Similar | | Material | Nitrile | Nitrile | Same | | Color | Blue | Blue | Same | | CHARACTERISTIC | PREDICATE DEVICE K162646 | SUBJECT DEVICE | COMPARISON | | Size | XS, S, M, L, XL | XS, S, M, L, XL | Same | | Dimensions | Meets ASTM D6319-10 Thickness at Finger - min. 0.05mm Thickness at Palm - min. 0.05mm Length - Min. 230 mm Width - M - 95±10mm | Meets ASTM D6319-19 Thickness at Finger - min. 0.05mm Thickness at Palm - min. 0.05mm Length - Size XS, S, M, L, XL - Min. 230 Width - XS- 70±10mm S- 80±10mm M- 95±10mm L- | Similar | | Physical Properties | Meets ASTM D6319-10. Tensile Strength: Before Aging Min. 14 MPa Ultimate Elongation: Before Aging min. 500% | Meets ASTM D6319-19. Tensile Before Aging Min. 14 MPa Ultimate Elongation Before Aging min. 500% | Same | | | After Aging Min. 14 MPa After Aging min. 400% | After Aging Min. 14 MPa After Aging min. 400% | | | Powder Content | Meets ASTM 6124-06 (2011) (≤ 2 mg/glove) | Meets ASTM 6124-06 (2022) (≤ 2 mg/glove) | Same | | Freedom from Holes | Meets ASTM D5151-06. | Meets ASTM D5151-19. | Same | | CHARACTERISTIC | PREDICATE DEVICE K162646 | SUBJECT DEVICE K241528 | COMPARISON | | Low Dermatitis Potential | Meets Modified Draize ASTM 6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. | Meets Modified Draize ASTM 6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. | Same | | Biocompatibility: Irritation Tests | Under the conditions of the study, the subject device is non- irritating. | Under the conditions of the study, the subject device is non- irritating. | Same | | Biocompatibility: Skin Sensitization Tests | Under the conditions of the study, the subject device is not sensitizing. | Under the conditions of the study, the subject device is not sensitizing. | Same | | Biocompatibility: Cytotoxicity | No test report was submitted for the predicate. | Under the conditions of the study, the subject device extract exhibits mild | Different | | Biocompatibility: Acute systemic Toxicity | No test report was submitted for the predicate. | Did not induce any acute systemic toxicity in swiss albino mice under the conditions of the study. | Different | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ #### 8.0 Summary of Non-Clinical Performance Data 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: | Test | Standard | Acceptance Criteria | Results | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Physical Dimensions Thickness | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application | ISO 2859-1/S2/AQL 4.0 Length - Size XS, S, M, L, XL – Min. 230 Width - XS - 70±10mm S – 80±10mm M – 95±10mm L – 110±10mm XL – 120±10mm Thickness at Finger – min. 0.05mm Thickness at Palm – min. 0.05mm | Pass | | Physical Properties | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension | Before aging: Tensile Strength: ≥14 MPa Ultimate elongation: ≥500% After aging: Tensile Strength: ≥14 MPa Ultimate elongation: ≥400% | Pass | | Powder Residue | ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves | ≤ 2 mg/glove | Pass | | Freedom from Holes | ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves | AQL 1.5 | Pass | | Irritation | ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation | Under the conditions of the study, the device is not an irritant. | Under the conditions of the study, the device was not an irritant. | | Sensitization | ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization | Under the conditions of the study, the device is not a sensitizer. | Under the conditions of the study, the device was not a sensitizer. | | Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity | Under the conditions of the study, the subject device extract does not exhibit cytotoxicity reactivity. | Under the conditions of the study, the subject device extract exhibits cytotoxicity from 100.0 % extract concentrations to 50.0 % extract concentrations and no cytotoxicity reactivity from 25.0 % extract concentrations to 3.125 % extract concentrations. | | Acute systemic toxicity | ISO 10993-11 Biological evaluation on medical device Part 11 - Test for systemic toxicity | Under the conditions of this study, the test article does not induce acute systemic toxicity. | Under the conditions of this study, the test article did not induce acute systemic toxicity. | | Low Dermatitis Potential | Modified Draize ASTM 6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. | No clinical evidence that the glove may induce Type IV allergy in the unsensitized general user population. | There was no clinical evidence that the glove may induce Type IV allergy in the unsensitized general user population. | {10}------------------------------------------------ {11}------------------------------------------------ ## 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.

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

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Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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