(91 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.
The powder free nitrile examination glove is manufactured from nitrile rubber. 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.
This document is a 510(k) premarket notification for a medical device: a powder-free nitrile examination glove. It demonstrates substantial equivalence to a predicate device, not the performance of an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/diagnostic study is not applicable to this document.
For context, here's what aspects of a glove would be tested and reported on, which is very different from an AI/diagnostic device:
Acceptance Criteria and Device Performance (for a glove, as per the document):
| Characteristic | Standard | Acceptance Criteria | Device Performance |
|---|---|---|---|
| Physical Properties | |||
| Tensile Strength (Before Aging) | ASTM D412 | Min 14.0 MPa | 31.4 MPa |
| Ultimate Elongation (Before Aging) | ASTM D412 | Min 500% | 577% |
| Tensile Strength (After Aging) | ASTM D412 | Min 14.0 MPa | 34.1 MPa |
| Ultimate Elongation (After Aging) | ASTM D412 | Min 400% | 541% |
| Dimensions | ASTM D3767 | ||
| Length (all sizes) | Min 240 mm | 249-250 mm | |
| Width (X-Small) | 70 ± 10 mm | 78.0 mm | |
| Width (Small) | 80 ± 10 mm | 88.0 mm | |
| Width (Medium) | 95 ± 10 mm | 98.0 mm | |
| Width (Large) | 110 ± 10 mm | 108 mm | |
| Width (X-Large) | 120 ± 10 mm | 118 mm | |
| Finger Thickness | Min 0.05 mm | 0.10 mm | |
| Palm Thickness | Min 0.05 mm | 0.07 mm | |
| Watertight | ASTM D5151 | AQL 1.5, Acceptance No. 10 (for a sample size of 315 pcs) | 1 piece with leaks (within acceptance criteria) |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove | 0.21 mg/glove |
Here's why the other requested information is not present in this document:
- Sample size used for the test set and the data provenance: For a physical product like a glove, "test set" refers to the number of gloves sampled for various physical and chemical tests (e.g., 315 for watertightness, 5 for residual powder). This is not a "data provenance" in the sense of patient data; the "data" comes from the physical product itself. The provenance would be the manufacturing site (Malaysia). These are product quality tests, not clinical studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a glove relies on standardized test methods (ASTM, ISO) and laboratory measurements of physical properties, not expert human interpretation.
- Adjudication method: Not applicable for physical product testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: "No clinical study is included in this submission" (Page 13). This type of study is relevant for diagnostic devices (especially AI-powered ones) to assess human performance with and without AI assistance, not for a simple examination glove.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component in this device.
- The type of ground truth used: For this device, "ground truth" is established through adherence to recognized international standards for glove manufacturing and testing (e.g., ASTM, ISO standards). For biocompatibility, it's lab test results (e.g., cytotoxicity, irritation, sensitization).
- The sample size for the training set: Not applicable. This is a physical product, not an AI model that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided document is a regulatory submission for a physical medical device (examination glove) demonstrating substantial equivalence, not a study validating an AI/diagnostic device. Therefore, the specific criteria for assessing an AI/diagnostic device's performance are not found in this type of document.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Hong Seng Gloves Sdn Bhd % Michael Van Der Woude U.S. Agent Emergo Global Representative LLC, 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746
Re: K212802
Trade/Device Name: powder free nitrile examination glove - white, non-sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 12, 2021 Received: September 2, 2021
Dear Michael Van Der Woude:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher K. Dugard -S
For Clarence W. Murray, III, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K212802
Device Name POWDER FREE NITRILE EXAMINATION GLOVE - WHITE, NON STERILE
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)
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1.0 Submitter:
| Name: | Ho Chia Yao |
|---|---|
| Address: | Hong Seng Gloves Sdn BhdLot 97, Jalan 10, Kawasan Perusahaan Bakar Arang, 08000Sungai Petani, Kedah, Malaysia. |
| Phone No.: | +604-4211555 |
| Fax No.: | +604-4211555 |
Date of Summary Prepared: 20th July 2021(Amended on 24th Nov 2021)
2.0 Identification of the subject device:
| Trade Name | : Powder Free Nitrile Examination Glove - White, Non-Sterile |
|---|---|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : 1 |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA. |
3.0 Predicate Device:
K171615
Xingyu Nitrile Powder Free Patient Examination Gloves, White Color Company: Shandong Xingyu Gloves Co., Ltd
Description of The Device: 4.0
Powder Free Nitrile Examination Glove - White, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from nitrile rubber. 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.
5.0 Indication for use:
A patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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Comparison of the Technological Characteristics of the Device: 6.0
The Powder Free Nitrile Examination Glove - White, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.
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Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATE | CURRENT | |||
| WHITE | WHITE | |||
| 510(k) Number | - | K171615 | ||
| Manufacturer(s) | - | Shandong Xingyu Gloves Co., Ltd | Hong Seng Gloves Sdn Bhd | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | White | White | Same |
| Physical Properties | ASTM D6319 | |||
| Before AgingTensile Strength:Ultimate Elongation: | 18-25Mpa560-600% | 31.4Mpa577% | Different butwithin the ASTMstandard | |
| After AgingTensile Strength:Ultimate Elongation: | 17-21Mpa460-560% | 34.1Mpa541% | Different butwithin the ASTMstandard | |
| Thickness:- Finger- Palm | ASTM D6319 | 0.08mm0.08mm | 0.10mm0.07mm | Different butwithin the ASTMstandard |
| Powder Free | ASTM D6124 | Below 2mg of residual powder | 0.21 mg/glove | Different butwithin the ASTMstandard |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATE | CURRENT | |||
| WHITE | WHITE | |||
| Biocompatibility | Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Under the conditions of thisstudy, the test article was anon-irritant or non-sensitizer.SKIN IRRITATION DERMAL andSENSITIZATION STUDIES MeetsISO 10993-10: Third Edition2010-08-01 | The test material did not causean irritant response. ThePrimary Irritant ResponseCategory is deemed 'Negligible' | Similar |
| Dermal Sensitization-ISO 10993-10: 2010(E) & ConsumerProduct SafetyCommission, Title 16,Chapter II, Part1500.3 (c) (4) | Under the conditions of thisstudy, the test article was anon-irritant or non-sensitizer.SKIN IRRITATION DERMAL andSENSITIZATION STUDIESMeets ISO 10993-10: ThirdEdition 2010-08-01 | The test material did notproduce a skin sensitizationeffect in the guinea pigs. | Similar | |
| Cytotoxicity - MEMElution, ISO 10993-5:2009 (E) | Not Tested | The test materialdemonstrated a cytotoxiceffect under the condition ofthis study. Additional test i.e.Acute Systemic Toxicity wastested | Different | |
| DEVICE PERFORMANCE | ||||
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS |
| WHITE | WHITE | |||
| Biocompatibility | Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Tested | The test item did not induceany systemic toxicity in Swissalbino mice. | Different |
| Watertight (1000ml) | ASTM D5151:2019 | Meets21 CFR 800.20ASTM D6319-10(Reapproved 2015) Tested in accordance with ASTMD5151 (Reapproved 2015) withacceptable results | Gloves passed AQL 1.5 | Similar |
| Intended use | - | Powder Free Nitrile PatientExamination Gloves, WhiteColor is a disposable deviceintended for medical purposesthat is worn on the examiner'shand or finger to preventcontamination between patientand examiner. | A patient examination glove is adisposable device made ofnitrile rubber intended formedical purposes that is wornon the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Same |
| Size | Medical GloveGuidance Manual -Labeling | SmallMediumLargeX Large | Extra SmallSmallMediumLargeExtra Large | Similar |
| Single use | Medical GloveGuidance Manual -Labeling | Single Patient Use | Single Use | Same |
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There are no significant differences between the two products and they are the same or similar in terms of intended use, materials design, physical properties, thickness and biocompatibility test.
7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.
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| TestMethod | Standard | Purpose of Testing | Acceptance CriteriaBeforeaging | Afteraging | ResultsBeforeaging | Afteraging | Status | |
|---|---|---|---|---|---|---|---|---|
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Min 14.0MPa | Min 14.0MPa | 31.4Mpa | 34.1Mpa | Pass |
| Ultimateelongation | Min500% | Min400% | 577% | 541% | Pass |
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| TestMethod | Standard | Purpose ofTesting | GloveSize | Acceptance Criteria | Results | Status | |
|---|---|---|---|---|---|---|---|
| Dimension | ASTM D3767StandardPractice forRubber—Measurementof Dimensions | To measure thelength, width andthickness ofglove | X-Small | LengthMin 240 mm | Length250 mm | Pass | |
| Width$70 \pm 10$ mm | Width78.0 mm | Pass | |||||
| ThicknessFinger - min 0.05mmPalm - min 0.05mm | Thickness0.10 mm0.07 mm | Pass | |||||
| Small | LengthMin 240 mm | Length250 mm | Pass | ||||
| Width$80 \pm 10$ mm | Width88.0 mm | Pass | |||||
| ThicknessFinger - min 0.05mmPalm - min 0.05mm | Thickness0.10 mm0.07 mm | Pass | |||||
| Medium | LengthMin 240 mm | Length249 mm | Pass | ||||
| Width$95 \pm 10$ mm | Width98.0 mm | Pass | |||||
| ThicknessFinger - min 0.05mmPalm - min 0.05mm | Thickness0.10 mm0.07 mm | Pass | |||||
| Large | LengthMin 240 mm | Length249 mm | Pass | ||||
| Width$110 \pm 10$ mm | Width108 mm | Pass | |||||
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | |||
| Palm - min 0.05mm | 0.07 mm | ||||||
| Length | Min 240 mm | Length | 250 mm | Pass | |||
| X-Large | Width | $120 \pm 10$ mm | Width | 118 mm | Pass | ||
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | |||
| Palm - min 0.05mm | 0.07 mm |
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| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves) | To detect holesthat leak waterand therebycompromise theusefulness of theglove. | Sample size: 315 pcsInspection level: G1AQL: 1.5, Acceptance No.10 | The batch size for thissampling is 150,001 to500,000. Hence,according to the singlesampling plan G1, thesample to be drawn isunder code Mequivalent to 315pieces with accept 10and reject 11 to beaccepted under AQL1.5. During the test, 1piece was found withleaks. Hence it fallswithin the acceptancecriteria. | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status |
|---|---|---|---|---|---|
| ResidualPowder | ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determine theamount ofresidual powderand non-powdersolids found ongloves. | Less than 2 mg per glove | Sample size : 5 pcsRequirement : <2mg/gloveResult :0.21mg/glove | Pass |
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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 Powder Free Nitrile Examination Glove - White, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices Xingyu Nitrile Powder Free Patient Examination Gloves, White Color (K171615).
§ 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.