(116 days)
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.
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo 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.
This document is a 510(k) premarket notification for a medical device: "Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)" manufactured by WRP Asia Pacific Sdn Bhd.
Based on the provided information, the acceptance criteria and the study that proves the device meets them are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D412-16 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension) | ||
| Tensile Strength (Before Aging) | To evaluate the tensile (tension) properties of glove. | Min 14.0 MPa | 24.5 MPa (Average) |
| Ultimate Elongation (Before Aging) | To evaluate the tensile (tension) properties of glove. | Min 500% | 547% |
| Tensile Strength (After Aging) | To evaluate the tensile (tension) properties of glove. | Min 14.0 MPa | 26.4 MPa (Average) |
| Ultimate Elongation (After Aging) | To evaluate the tensile (tension) properties of glove. | Min 400% | 449% |
| Dimension | ASTM D3767 - 03(2014) Standard Practice for Rubber—Measurement of Dimensions | To measure the length, width and thickness of glove. | |
| Length | To measure the length, width and thickness of glove. | Min 240 mm | Min 242 mm |
| Width | To measure the length, width and thickness of glove. | Min 95 ± 10 mm | 95 mm |
| Thickness - Finger | To measure the length, width and thickness of glove. | 0.05 mm (Note: This appears to be a minimum threshold given the "Palm" entry; it's stated as "0.05 mm" without min/max, but context suggests a minimum) | 0.22 mm |
| Thickness - Palm | To measure the length, width and thickness of glove. | 0.05 mm (Note: This appears to be a minimum threshold given the "Finger" entry; it's stated as "0.05 mm" without min/max, but context suggests a minimum) | 0.21 mm |
| Watertight | ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves) | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10. (For a batch size of 150,001 to 500,000, under code M, 315 pieces are drawn, with acceptance allowed if 10 or fewer leaks are found.) | During the test, 2 pieces were found with leaks. Hence it falls within the acceptance criteria. (The batch size for this sampling is 150,001 to 500,000. Hence, according to the single sampling plan GI, the sample to be drawn is under code M equivalent to 315 pieces with accept 10 and reject 11 to be accepted under AQL 1.5.) |
| Residual Powder | ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves) | Less than 2 mg per glove | 1.9 mg/glove (Sample size: 5 pcs) |
2. Sample size(s) used for the test set and the data provenance:
- Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but typically involves multiple samples per batch/test condition to derive an average. The standards (ASTM D412-16) would specify the required sample size.
- Dimension: Not explicitly stated, but typically involves multiple samples per batch/test condition to derive an average. The standards (ASTM D3767 - 03(2014)) would specify the required sample size.
- Watertight:
- Sample Size: 315 pieces
- Data Provenance: The data is from non-clinical testing performed on the device itself. The country of origin of the data is not specified, but the manufacturer is WRP Asia Pacific Sdn Bhd in Malaysia. This is prospective testing on the manufactured device.
- Residual Powder:
- Sample Size: 5 pieces
- Data Provenance: Non-clinical testing on the device. Country of origin not specified, manufacturer is Malaysian. This is prospective testing.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): These tests were performed, and results indicated "Passes" or "Not a primary skin irritant/contact sensitizer" or "Exhibit severe cytotoxicity reactivity at 100%, 66%, and 44% extract concentration. Moderate cytotoxicity reactivity at 30%, mild cytotoxicity reactivity at 20% and slight cytotoxicity reactivity at 15% extract concentrations." and "It is concluded that the extracts (polar and non-polar) of the product did not show any systemic toxicity." The exact number of samples (and animals for in-vivo tests) used for these biocompatibility tests is not detailed in the provided summary, but the standards (ISO 10993 series and Consumer Product Safety Commission regulations) would dictate the sample sizes. Data provenance is non-clinical testing on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document describes non-clinical performance testing of a physical medical device (gloves). The "ground truth" for these tests is established by published, internationally recognized standards (ASTM, ISO, FDA 21 CFR, CPSC regulations) and the objective measurements derived from these tests. These studies do not involve human experts establishing a subjective ground truth, as would be the case for AI/diagnostic imaging devices. Therefore, this information is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving subjective human interpretation that would require an adjudication method. The testing involves objective physical and chemical measurements against pre-defined 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 a 510(k) submission for a physical medical device (examination gloves), not an AI/Software as a Medical Device (SaMD) that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance characteristics of these gloves is defined by:
- Standardized Test Methods: ASTM D412-16, ASTM D3767 - 03(2014), ASTM D5151-06, ASTM D6124-06.
- Regulatory Standards: FDA 21 CFR 880.6250.
- Biocompatibility Standards: ISO 10993-10:2002(E), ISO 10993-5:2009 (E), ISO 10993-11:2017 (E), and Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.
These standards provide objective, measurable criteria for the glove's performance.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. No training set is involved.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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.
January 17, 2020
Wrp Asia Pacific Sdn Bhd Hasnah Hamid Quality Assurance Manager Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, 43900 My
Re: K192635
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 24, 2019 Received: October 28, 2019
Dear Hasnah Hamid:
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,
For Elizabeth Claverie, M.S. 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) K192635
Device Name
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange)
Indications for Use (Describe)
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.
| 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:
| Name: | Hasnah Abdul Hamid |
|---|---|
| Address: | WRP Asia Pacific Sdn BhdLot 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: 10th January 2020
2.0 I dentification of the subject device:
Trade Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves Device Classification: I Regulation Number: 21 CFR 880.6250 Product Code: LZA
3.0 Predicate Device:
K133168
Dermagrip Powder Free Blue Nitrile Examination Gloves WRP Asia Pacific Sdn Bhd
Description of The Device: 4.0
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove is manufactured from synthetic rubber Inner surface of gloves undergo surface treatment process to produce a latex. 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.
5.0 Indication for Use:
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.
{4}------------------------------------------------
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves, Non-Sterile (Orange) are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | |
|---|---|---|---|---|
| PREDICATEBLUE | CURRRENTORANGE | |||
| 510(k) Number | - | K133168 | K192635 | Not Available |
| Manufacturer(s) | - | WRP Asia Pacific Sdn Bhd | WRP Asia Pacific Sdn Bhd | Same |
| Material | ASTM D6319-10 | Nitrile | Nitrile | Same |
| Color | - | Blue | Orange | Different |
| Texture | - | Finger textured(Textured only at the fingerpart) | Hand textured(Fully textured surface fromfingertips to end of palm) | Different |
| Physical Properties | ASTM D6319-10 | |||
| Before Aging | ||||
| Tensile Strength : | 14MPa min | 14MPa min | Same | |
| Ultimate Elongation : | 500% min | 500% min | ||
| After Aging | ||||
| Tensile Strength : | 14MPa min | 14MPa min | Same | |
| Ultimate Elongation : | 400% min | 400% min | ||
| Thickness - Finger | ASTM D6319-10 | 0.07-0.10mm | 0.21–0.23mm | Different |
| - Palm | 0.07-0.09mm | 0.19-0.22mm | ||
| - Cuff | 0.06-0.08mm | 0.10-0.12mm | ||
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATE BLUE | CURRRENT ORANGE | |||
| Biocompatibility | Primary Skin Irritation -ISO 10993-10:2002(E)&Consumer ProductSafety Commission,Title 16, Chapter II, Part1500 | Passes (Not a primary skinirritant)There was no erythema oroedema noted on test siteafter (24±2), (48±2) and(72±2) hours. The primaryIrritation Index (PII) was "0" | Passes (Not a primary skin irritant)There was no erythema or oedemanoted on test site after (24±2), (48±2)and (72±2) hours. The primaryIrritation Index (PII) was "0" | Similar |
| Biocompatibility | Dermal Sensitization-ISO 10993-10:2002 (E)& Consumer ProductSafety Commission,Title 16, Chapter II, Part1500.3 (c) (4) | Passes (Not a contactsensitizer)There was no positive allergicreaction observed during thechallenge phase (at 24 hoursand 48 hours) in animalstreated with the test materialand negative control. | Passes (Not a contact sensitizer)There was no positive allergic reactionobserved during the challenge phase(at 0, 24 hours and 48 hours) inanimals treated with the test materialand negative control. | Similar |
| Biocompatibility | Cytotoxicity — MEMElution,ISO 10993-5:2009 (E) | Not available. | Exhibit severe cytotoxicity reactivity at100%, 66%, and 44% extractconcentration.Moderate cytotoxicity reactivity at30%, mild cytotoxicity reactivity at20% and slight cytotoxicity reactivityat 15% extract concentrations.Cytotoxicity concern wasaddressed by acute systematictoxicity testing. | Different |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATEBLUE | CURRENTORANGE | |||
| Biocompatibility | Acute Systemic Toxicity,ISO 10993-11:2017 (E) | Not Available | It is concluded that theextracts (polar and non -polar) of the product did notshow any systemic toxicity. | Different |
| Watertight (1000ml) | ASTM D5151-06 | InspectionLevel 1, AQL 1.5 | InspectionLevel 1, AQL 1.5 | Same |
| Intended use | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination between patientand examiner. | A patient examination gloveis a disposable deviceintended for medical purposesthat is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer. | Same | |
| Size | Medical Glove GuidanceManual - Labeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Similar |
| Single Use | Medical Glove GuidanceManual - Labeling | Single use | Single use | Same |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for color and thickness. The current device is orange in color and thicker than predicate device.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below.
{8}------------------------------------------------
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | ||
|---|---|---|---|---|---|---|---|
| PhysicalProperties | ASTM D412-16(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Beforeaging | Afteraging | Beforeaging | Afteraging | |
| Min 14.0MPa | Min 14.0MPa | 24.5 MPa(Average) | 26.4 MPa(Average) | Pass | |||
| Min500% | Min400% | 547% | 449% | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Dimension | ASTM D3767 -03(2014)Standard Practicefor Rubber—Measurement ofDimensions | To measure thelength, widthand thickness ofglove | LengthMin 240 mm | LengthMin 242 mm | Pass |
| WidthMin 95 ± 10 mm | Width95 mm | Pass | |||
| ThicknessFinger – 0.05 mmPalm – 0.05 mm | ThicknessFinger – 0.22 mmPalm – 0.21 mm | Pass | |||
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
| Watertight | ASTM D5151 - 06(Standard TestMethod forDetection of Holes inMedical Gloves) | To detect holesthat leak waterand therebycompromise theusefulness of | Sample size: 315 pcsInspection level: G1AQL: 1.5, Acceptance No. 10,Found 2 | The batch size for thissampling is 150,001 to500,000. Hence,according to the single | Pass |
{9}------------------------------------------------
| the glove. | sampling plan GI, thesample to be drawn isunder code M equivalentto 315 pieces with accept10 and reject 11 to beaccepted under AQL 1.5.During the test, 2 pieceswere found with leaks.Hence it falls within theacceptance criteria. | ||||
|---|---|---|---|---|---|
| -- | -- | ------------ | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124-06(Standard TestMethod for ResidualPowder on MedicalGloves) | To determinethe amount ofresidual powderand non-powdersolids found ongloves. | Less than 2 mg per glove | Sample size : 5 pcsRequirement : <2mg/gloveResult : 1.9 mg/glove | Pass |
{10}------------------------------------------------
Summary of Clinical Testing 8.0
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical test demonstrate that the subject Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K133168.
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.