(90 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 Examination Glove - Blue, 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.
This document is a 510(k) Premarket Notification from the FDA for a Powder Free Nitrile Examination Glove. It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence.
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of acceptance criteria and the reported device performance
The relevant table is "Table 1" and the "Summary of Non-Clinical Testing" section. They outline the acceptance criteria, primarily based on ASTM standards, and the performance of the device and the predicate device.
| Characteristic / Test Method | Acceptance Criteria (from ASTM D6319 or other standards) | Device Performance (Current Blue Glove) | Status |
|---|---|---|---|
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Texture | Finger texture | Finger Texture | Same |
| Physical Properties (ASTM D6319) | |||
| Before Aging | Tensile Strength: Min 14.0 MPa; Ultimate Elongation: Min 500% | Tensile Strength: 28.6 MPa; Ultimate Elongation: 579% | Pass |
| After Aging | Tensile Strength: Min 14.0 MPa; Ultimate Elongation: Min 400% | Tensile Strength: 33.1 MPa; Ultimate Elongation: 535% | Pass |
| Thickness (ASTM D6319) | Finger: Min 0.05mm; Palm: Min 0.05mm | Finger: 0.10mm; Palm: 0.07mm | Pass |
| Powder Free (ASTM D6124) | Less than 2 mg per glove | 0.26 mg/glove | Pass |
| Watertight (ASTM D5151) | AQL: 1.5, Acceptance No. 10 (for 500 pcs tested) | 1 leak found in 500 pcs, which falls within acceptance criteria. | Pass |
| Size (Medical Glove Guidance Manual) | Standard ranges for Length and Width based on size (X-Small to X-Large) | Ranges met for all sizes (X-Small to X-Large) | Pass |
| Single Use (Medical Glove Guidance Manual) | Single Use | Single Use | Same |
| Biocompatibility (ISO 10993-10:2010 (E)) | Not an irritant | "Negligible" irritant response | Similar |
| Biocompatibility (ISO 10993-10:2010 (E)) | Not a sensitizer | No skin sensitization effect | Similar |
| Biocompatibility (ISO 10993-5:2009 (E)) | Cytotoxicity (Additional testing if cytotoxic) | Demonstrated cytotoxic effect, followed by Acute Systemic Toxicity test. | Similar |
| Biocompatibility (ISO 10993-11:2017 (E)) | Device extracts do not pose a systemic toxicity concern | No systemic toxicity induced | Similar |
The "Comparison Analysis" column in Table 1 notes that some characteristics (Tensile Strength, Ultimate Elongation, Thickness, Powder Free) are "Different but within the ASTM standard," indicating they meet the acceptance criteria despite not being identical to the predicate device.
2. Sample sized used for the test set and the data provenance
- Physical Properties (Tensile Strength, Elongation): Sample size is not explicitly stated for these tests within the provided text, but it commonly involves multiple samples to determine average values. The data provenance is implied to be from Hong Seng Gloves Sdn Bhd, Malaysia, as they are the submitter and manufacturer. This is retrospective testing done by the manufacturer to demonstrate compliance.
- Watertight:
- Sample size: 500 pieces were tested. The batch size for this sampling was 150,001 to 500,000, and according to the single sampling plan G1, the sample drawn was code M equivalent to 315 pieces, but 500 pcs were tested.
- Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia), as part of their non-clinical testing. This is retrospective testing.
- Powder Free:
- Sample size: 5 pieces (as stated in the "Summary of Non-Clinical Testing" table under "Results" for Powder Free).
- Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia). Retrospective testing.
- Dimension:
- Sample size: Not explicitly stated for each size, but dimension measurements would typically involve multiple gloves per size.
- Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia). Retrospective testing.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): Sample sizes for biological tests (e.g., number of animals for irritation/sensitization, cell cultures for cytotoxicity) are not specified, but the tests were performed "under the conditions of the study" and passed relevant ISO standards.
- Data Provenance: These are specified as being performed according to ISO standards, implying accredited lab testing, likely commissioned by the manufacturer. Retrospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes a 510(k) submission for a Class I medical device (examination glove). The ground truth for this type of device is established through performance against recognized industry standards (e.g., ASTM, ISO).
- No human "experts" in the sense of clinicians or radiologists are used to establish ground truth for performance testing in this context. The ground truth is objective, quantifiable measurements against pre-defined engineering and safety standards.
- Therefore, the concepts of "number of experts" and "qualifications of those experts" (like radiologists with 10 years of experience) are not applicable to the non-clinical performance testing described here.
4. Adjudication method
- As the ground truth is established by objective measurements against ASTM/ISO standards, there is no adjudication method (like 2+1 or 3+1 consensus) required for these types of tests. The results are quantitative and directly compared to the numerical acceptance criteria.
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
- No MRMC study was performed. This device is a physical examination glove, not an AI-powered diagnostic tool or an imaging device. The concept of "human readers improving with AI assistance" is entirely irrelevant to this product submission.
- The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an examination glove, not an algorithm. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used
- The ground truth used for this device's performance evaluation is based on established national and international consensus standards for physical properties and biocompatibility of medical gloves, specifically:
- ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (presumably variations are used for physical properties before/after aging)
- ASTM D3767: Standard Practice for Rubber--Measurement of Dimensions
- ISO 10993-10:2010 (E): Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
- ISO 10993-5:2009 (E): Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-11:2017 (E): Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- Medical Glove Guidance Manual – Labeling
8. The sample size for the training set
- Not applicable. This submission is for a physical medical device (a glove) and does not involve AI or machine learning algorithms that require a "training set." The testing outlined is for product quality and safety validation, not algorithm development.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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December 1, 2021
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: K212804
Trade/Device Name: Powder free nitrile examination glove- blue, 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
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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 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,
For Clarence W. Murray III, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212804
Device Name POWDER FREE NITRILE EXAMINATION GLOVE - BLUE, 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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510(k) SUMMARY
K212804
1.0 Submitter:
| Name: | Ho Chia Yao |
|---|---|
| Address: | Hong Seng Gloves Sdn BhdLot 97, Jalan 10, Kawasan Perusahaan Bakar Arang, 08000,Sungai Petani, Kedah, Malaysia |
| Phone No.: | +604-4211555 |
| Fax No.: | +604-4211555 |
Date of Summary Prepared: 20th July 2021 (REVISED DATE: 30th NOVEMBER 2021)
2.0 Identification of the subject device:
| Trade Name | : Powder Free Nitrile Examination Glove - Blue, 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:
K192333
Blue Nitrile Examination Gloves Powder Free Company: JR Engineering & Medical Technologies (M) SDN. BHD.
4.0 Description of The Device:
Powder Free Nitrile Examination Glove - Blue, 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 Intended Use/Indication for use:
A patient examination glove is a disposable device made of nitrile rubberintended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Comparison of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Glove - Blue, 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
| CHARACTERISTICSSTANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | ||
|---|---|---|---|---|
| PREDICATEBLUE | CURRENTBLUE | |||
| 510(k) Number | - | K192333 | K212804 | |
| Manufacturer(s) | - | JR Engineering & MedicalTechnologies (M) SDN. BHD. | Hong Seng Gloves Sdn Bhd | Same |
| Intendeduse/Indications for Use | - | JR MEDIC Blue Nitrile ExaminationGloves Powder Free is disposabledevices intended for medical purposethat are worn on the examiner'shand to prevent contaminationbetween patient and examiner. | A patient examination glove is adisposable device made of nitrilerubber intended for medicalpurposes that is worn on theexaminer's hand or finger to preventcontamination between patient andexaminer. | Same |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger texture | Finger Texture | Same |
| Physical PropertiesBefore AgingTensile Strength:Ultimate Elongation: | ASTM D6319 | 25.6Mpa868% | 28.6Mpa579% | Different butwithin the ASTMstandard |
| After AgingTensile Strength:Ultimate Elongation: | ASTM D6319 | 22.0Mpa828% | 33.1Mpa535% | Different butwithin the ASTMstandard |
| Thickness:- Finger- Palm | ASTM D6319 | 0.22mm0.20mm | 0.10mm0.07mm | Different butwithin the ASTMstandard |
| Powder Free | ASTM D6124 | 0.21 mg/glove | 0.26 mg/glove | Different butwithin the ASTMstandard |
| Watertight (1000ml) | ASTMD5151:2019 | Gloves passes AQL 1.5 | Gloves passed AQL 1.5 | Same |
| Size | Medical GloveGuidance Manual– Labeling | Extra Small Small Medium LargeExtra Large | Extra Small Small Medium LargeExtra Large | Same |
| Single use | Medical GloveGuidance Manual– Labeling | Single Use | Single Use | Same |
| Primary SkinIrritation– ISO 10993-10:2010(E) | Under the condition of study not anirritant | The test material did not cause anirritant response. The PrimaryIrritant Response Category isdeemed `Negligible' | Similar | |
| DermalSensitization- ISO10993-10: 2010(E) | Under the conditions of the study nota sensitizer | The test material did not produce askin sensitization effect in the guineapigs. | Similar | |
| Biocompatibility | Cytotoxicity -MEM Elution, ISO10993-5:2009 (E) | Under the conditions of the study,cytotoxic. Additional testing wasperformed to determine if this was asystemic toxicity concern. | The test material demonstrated acytotoxic effect under the conditionof this study. Additional test i.e.Acute Systemic Toxicity wastested. | Similar |
| Acute SystemicToxicity, ISO10993-11:2017 (E) | Under the conditions of study, thedevice extracts do not pose asystemic toxicity concern | The test item did not induce anysystemic toxicity in Swiss albinomice. | Similar |
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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.
| TestMethod | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Beforeaging | Afteraging | Beforeaging | After aging | |||||
| PhysicalProperties | ASTM D412(Standard TestMethod for VulcanizedRubber andThermoplasticElastomers-Tension) | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Min14.0MPa | Min 14.0MPa | 28.6Mpa | 33.1Mpa | Pass |
| Ultimateelongation | Min500% | Min400% | 579% | 535% | Pass | |||
| Watertight | ASTM D5151(Standard TestMethod forDetection of Holes inMedical Gloves) | To detect holes thatleak water andthereby compromisethe usefulness of theglove. | Sample size: 500 pcs Inspectionlevel: G1AQL: 1.5, Acceptance No. 10 | Less than 2 mg per glove | The batch size for this samplingis 150,001 to 500,000. Hence,according to the singlesampling plan GI, the sampleto be drawn is under code Mequivalent to 315 pieces withaccept 10 and reject 11 to beaccepted under AQL1.5. 500 pcs were tested, 1piece was found with leaks.Hence it falls within theacceptance criteria. | Pass | ||
| Sample size : 5 pcs | Requirement : <2mg/gloveResult :0.26mg/glove | 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 of glove | X-Small | LengthMin 240 mm | Length249 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 | Length249 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 | Width107 mm | Pass | |||||
| Thickness | Finger – min 0.05mmPalm – min 0.05mm | Thickness | 0.10 mm0.07 mm | Pass | |||
| Length | Min 240 mm | Length | 249 mm | Pass | |||
| X-Large | Width | $120 \pm 10$ mm | Width | 118 mm | Pass | ||
| Thickness | Finger - min 0.05mmPalm - min 0.05mm | Thickness | 0.10 mm0.07 mm | Pass |
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Summary of Clinical Testing: 8.0
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 - Blue, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K19233.
§ 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.