Who is the manufacturer of Powder Free Latex Examination Glove, Non-Sterile?

Wrp Asia Pacific Sdn. Bhd. filed the 510(k) submission for Powder Free Latex Examination Glove, Non-Sterile (K211601).

What is the FDA product code for Powder Free Latex Examination Glove, Non-Sterile?

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

What is the regulatory pathway for Powder Free Latex Examination Glove, Non-Sterile?

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

What are the predicate devices for Powder Free Latex Examination Glove, Non-Sterile?

Palm Care Latex Examination Powder Free Glove (K202377).

Who can help prepare an FDA 510(k) submission like Powder Free Latex Examination Glove, Non-Sterile?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Powder Free Latex Examination Glove, Non-Sterile

K211601 · Wrp Asia Pacific Sdn. Bhd. · LYY · Aug 22, 2022 · General Hospital

Device Facts

Record ID	K211601
Device Name	Powder Free Latex Examination Glove, Non-Sterile
Applicant	Wrp Asia Pacific Sdn. Bhd.
Product Code	LYY · General Hospital
Decision Date	Aug 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

Indications for Use

A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable natural rubber latex examination glove; non-sterile; powder-free. Ambidextrous design; finger-textured surface. Intended for use by healthcare professionals or in over-the-counter settings to prevent cross-contamination between patient and examiner. Manufactured via surface treatment to facilitate donning without lubricants. Supplied in sizes XS, XL. Device acts as a physical barrier. Performance verified against ASTM D3578 standards for tensile strength, elongation, and dimensions. Biocompatibility confirmed via ISO 10993 testing (irritation, sensitization, cytotoxicity, systemic toxicity). Watertightness verified per ASTM D5151. Shelf life established at 3 years per ASTM D7160.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM standards for physical properties (tensile strength, elongation), dimensions, watertightness (ASTM D5151), residual powder (ASTM D6124), and extractable protein (ASTM D5712-99). Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-irritant, and non-sensitizing properties.

Technological Characteristics

Material: Natural rubber latex. Form factor: Ambidextrous, finger-textured, powder-free. Standards: ASTM D3578 (physical properties), ASTM D5151 (watertightness), ASTM D6124 (residual powder), ASTM D5712 (protein content), ISO 10993 (biocompatibility). Sterilization: Non-sterile. Connectivity: None.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free natural rubber latex glove worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

Palm Care Latex Examination Powder Free Glove (K202377)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. August 22, 2022 WRP Asia Pacific SDN. BHD. % Michael Scaglione U.S. Agent SG Global, LLC 3700 Massillon Road, Suite 340 Uniontown, Ohio 44685 Re: K211601 Trade/Device Name: Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: July 18, 2022 Received: July 19, 2022 Dear Michael Scaglione: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K211601 Device Name Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free Indications for Use (Describe) A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. 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." {3}------------------------------------------------ #### 1.0 Submitter: | Sponsor: | WRP Asia Pacific Sdn. Bhd. | |---------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name: | Muhammad Ameer Arief bin Mohd Mujab | | Address: | WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | | Phone No.: | +60 3 8706 1486 | | Fax No.: | +60 3 8706 1485 | Date of Summary Prepared: 12th August 2022 #### 2.0 Identification of the subject device: | Trade Name | : Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free | |-----------------------|--------------------------------------------------------------------| | Common Name | : Patient Examination Gloves | | Classification Name | : Patient Examination Gloves | | Device Classification | : I | | Regulation Number | : 21 CFR 880.6250 | | Product Code | : LYY | #### 3.0 Predicate Device: | | PREDICATE DEVICE | |------------------|-----------------------------------------------| | Manufacturer | Hi-Care Thai Gloves Co. Ltd. | | Device Name | Palm Care Latex Examination Powder Free Glove | | 510 (k) Number | K202377 | | Regulatory Class | I | | Product Code | LYY | #### 4.0 Description of The Device: The Device meets all requirements of ASTM standard D3578 and FDA 21 CFR 880.6250. The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile. The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free. #### 5.0 Indication for use: A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. #### 6.0 Technological Characteristics Comparisons of the Device: {4}------------------------------------------------ ### Table 1 | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | |--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | | | PREDICATE | CURRENT | | | 510(k) Number | - | K202377 | K211601 | Different | | Manufacturer(s) | - | Hi-Care Thai Gloves Co. Ltd. | WRP Asia Pacific | Different | | Material | ASTM D3578 | Natural rubber latex | Natural rubber latex | Similar | | Color | - | Natural | Natural | Similar | | Texture | - | Finger textured | Finger textured | Similar | | Physical Properties | | Meets | Meets | | | Before Aging Tensile Strength: Ultimate Elongation: Stress at 500% Elongation: | ASTM D3578 | 18Mpa min 650% min 5.5Mpa max | 18MPa min 650% min 5.5Mpa max | Similar | | After Aging Tensile Strength: Ultimate Elongation: Stress at 500% Elongation: | ASTM D3578 | 14Mpa min 500% min - | 14MPa min 500% min - | Similar | | Thickness: - Finger - Palm | ASTM D3578 | Meets 0.08mm min 0.08mm min | Meets 0.11mm min 0.09mm min | Different but within the ASTM standard | | Powder Free | ASTM D6124 | Less than 2mg per glove | Less than 2mg per glove | Similar | | CHARACTERISTICS | DEVICE PERFORMANCE | | | | | | STANDARDS | PREDICATE | CURRENT | COMPARISON ANALYSIS | | Biocompatibility | Primary Skin Irritation - ISO 10993-10:2010 (E) & Consumer Product Safety Commission 2012 Title 16, Chapter II, Part 1500.3 & 1500.41 | Passes Not a primary skin irritant under the conditions of the study. | Passes (Not a primary skin irritant) There was no erythema or oedema noted on test site after (24±2), (48±2) and (72±2) hours. The primary Irritation Index (PII) was "0". | Similar | | | Dermal Sensitization- ISO 10993-10: 2010 (E) & Consumer Product Safety Commission 2012 Title 16, Chapter II, Part 1500.3 & 1500.41 | Passes Not a contact sensitizer under the conditions of the study. | Passes (Not a contact sensitizer). There was no positive allergic reaction observed during the challenge phase (at 0, 24 hours and 48 hours) in animals treated with the test material and negative control. | Similar | | | Determination of In Vitro Cytotoxicity Effect over L929 Cell Lines by Direct Contact Method, ISO 10993-5: 2009 (E) | Passes Non-cytotoxic under the conditions of the study. | Qualitative reactivity grading of cytotoxicity of the test item treatment was not greater than 2. Hence, the test item is considered as 'Non-cytotoxic" to L929 mouse fibroblast cells. | Similar | | | DEVICE PERFORMANCE | | | | | CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON ANALYSIS | | Biocompatibility | Acute Systemic Toxicity, ISO 10993-11:2017 (E) | Not systemic toxic under the conditions of the study. | It is concluded that the product did not induce any systemic toxicity. | Similar | | Watertight (1000ml) | ASTM D5151 | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Similar | | Intended use / Indications for use | | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | A 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. | Similar | | Size | Medical Glove Guidance Manual - Labeling | Extra small Small Medium Large | Extra small Small Medium Large Extra Large | Similar with additional size, XL for current device | | Single use | Medical Glove Guidance Manual - Labeling | Single use | Single use | Similar | | Sterility status | Medical Glove Guidance Manual - Labeling | Non-sterile | Non-sterile | Similar | | Extractable Protein Content | ASTM D5712-99 | 50 $µg/ dm²$ for all available sizes | <50 $µg/ dm²$ for all available sizes | Similar | | Shelf Life Claim | ASTM D7160 | No claim of shelf life | 3 years claim shelf life | Different | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ There are no significant differences between the subject and the predicate devices. The subject and predicate are identical in terms of intended use, materials, color, compliance with standards for physical properties, powder free and watertightness and sterility status. The sizes are similar with additional size, XL for current device. They are slightly differed in thickness; whereby the current device is thicker than the predicate device. On another hand, qualitative reactivity grading of cytotoxicity of the current device treatment was not greater than 2. Hence, the test item is considered as `Non-cytotoxic" to L929 mouse fibroblast cells. #### 7.0 Summary of Non-Clinical Testing The performance test data of the non-clinical test for this Glove are summarized as per below. {8}------------------------------------------------ | Test Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | | |------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------|--------------|--------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------| | | | | Before aging | After aging | Before aging | After aging | | | | Physical Properties | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers- Tension) | To evaluate the tensile (tension) properties of glove. | Tensile strength | Min 18.0 MPa | Min 14.0 MPa | Extra small - 24.40 MPa Small - 24.56 MPa Medium - 27.18 MPa Large - 26.51 MPa Extra Large - 26.11 MPa | Extra small - 25.59 MPa Small - 22.37 MPa Medium - 27.16 MPa Large - 25.95 MPa Extra Large - 26.67 MPa | Pass | | | | | Ultimate elongation | Min 650% | Min 500% | Extra small - 792 % Small - 808 % Medium - 817 % Large - 811 % Extra Large - 783 % | Extra small - 802 % Small - 723 % Medium - 809 % Large - 829 % Extra Large -785 % | Pass | | | | | Stress at 500% Elongation | Max. 5.5 MPa | - | Extra small - 4.77 MPa Small - 5.11 MPa Medium - 4.55 MPa Large - 4.85 MPa Extra Large - 5.22 MPa | Extra small - 4.39 MPa Small - 4.85 MPa Medium - 4.61 MPa Large - 3.17 MPa Extra Large - 5.09 MPa | Pass | {9}------------------------------------------------ | Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |----------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Dimension | ASTM D3767 Standard Practice for Rubber - Measurement of Dimensions | To measure the length, width and thickness of glove | Length Extra small – Min 240 mm Small – Min 240 mm Medium – Min 240 mm Large – Min 240 mm Extra Large – Min 240 mm Width Extra small – Max 80 mm Small – Min 80 ± 10 mm Medium - Min 95 ± 10 mm Large - Min 110 ± 10 mm Extra Large – Min 110mm Thickness Finger – Min 0.11 mm Palm – Min 0.09 mm | Length Extra small – 243 mm Small – 243 mm Medium - 243 mm Large - 243 mm Extra Large – 243 mm Width Extra small - 78 mm Small – 84 mm Medium - 95 mm Large – 106 mm Extra Large – 116 mm Thickness Finger Extra small – 0.14 Small – 0.14 mm Medium – 0.15 mm Large – 0.15 mm Extra Large – 0.16 mm Palm Extra small - 0.12 Small – 0.12 mm Medium – 0.12 mm Large – 0.12 mm Extra Large - 0.13 mm | Pass Pass Pass | | Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | | Watertight | ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves) | To detect holes that leak water and thereby compromise the usefulness of the glove. | Size: XS Sample size: 200 pcs Inspection level: G1 AQL: 1.0, Acceptance No. 5, Found 0 | The batch size for this sampling is 35,001 to 150,000. Hence, according to the single sampling plan GI, the sample to be drawn under code L is equivalent to 200 pieces with accept 5 and reject 6 to be accepted under AQL 1.0. During the test, 0 pieces were found with leaks. Hence it falls within the acceptance criteria. | Pass | | Watertight | | | Size: S Sample size: 500 pcs Inspection level: G1 AQL: 1.0, Acceptance No. 10, Found 1 | The batch size for this sampling is 500,001 to over. Hence, according to the single sampling plan GI, the sample to be drawn under code N equivalent to 500 pieces with accept 10 and reject 11 to be accepted under AQL 1.0. During the test, 1 piece was found with leaks. Hence it falls within the acceptance criteria. | Pass | | Watertight | | | Size: M Sample size: 500 pcs Inspection level: G1 AQL: 1.0, Acceptance No. 10, Found 3 | The batch size for this sampling is 500,001 to over. Hence, according to the single sampling plan GI, the sample to be drawn is under code N equivalent to 500 pieces with accept 10 and reject 11 to be accepted under AQL 1.0. During the test, 3 pieces were found with leaks. Hence it falls within the acceptance criteria. | Pass | | Watertight | | | Size: L Sample size: 500 pcs Inspection level: G1 AQL: 1.0, Acceptance No. 10, Found 3 | The batch size for this sampling is 500,001 to over. Hence, according to the single sampling plan GI, the sample to be drawn is under code M equivalent to 500 pieces with accept 10 and reject 11 to be accepted under AQL 1.0. During the test, 3 pieces were found with leaks. Hence it falls within the acceptance criteria. | Pass | | Watertight | | | Size: XL Sample size: 200 pcs Inspection level: G1 AQL: 1.0, Acceptance No. 5, Found 3 | The batch size for this sampling is 35,001 to 150,000. Hence, according to the single sampling plan GI, the sample to be drawn is under code L equivalent to 200 pieces with accept 5 and reject 6 to be accepted under AQL 1.0. During the test, 3 pieces were found with leaks. Hence it falls within the acceptance criteria. | Pass | {10}------------------------------------------------ {11}------------------------------------------------ | Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results (Sample size: 5 pcs) | Status | |--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------| | Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | To determine the amount of residual powder and non-powder solids found on gloves. | Have a powder residue limit of 2.0 mg per glove | Extra small – 0.2 mg Small – 0.5 mg Medium – 0.1 mg Large – 0.1 mg Extra Large – 0.2 mg | Pass | | Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results (Sample size: 3 pcs) | Status | |-----------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------|---------------------------------|--------| | Extractable Protein Content | ASTM D5712-99 (Standard Test Method for Analysis of Protein in Natural Rubber) | To determine the extractable protein in gloves | 200 µg/ dm² Max | Less than 50 µg/ dm² | Pass | The shelf-life study claim of this Glove describes the effect of accelerated aging on visual appearance, hole defect and physical properties for establishing a 3 years shelf life based on ASTM D7160. {12}------------------------------------------------ #### 8.0 Summary of Clinical Testing: No clinical study is included in this submission. #### 9.0 Conclusion The conclusion drawn from the non-clinical tests demonstrate that the subject Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K202377.

Powder Free Latex Examination Glove, Non-Sterile

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Powder Free Latex Examination Glove, Non-Sterile

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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