(122 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.
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile 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 provided text describes the acceptance criteria and performance data for the "Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile". This is a medical device, and the data presented relates to its physical properties and biocompatibility, not an AI/ML-based device. Therefore, questions related to AI/ML specific aspects like expert adjudication, MRMC studies, standalone algorithm performance, and training set details are not applicable.
Here's the analysis based on the provided text, focusing on the relevant criteria for this type of medical device:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ||||
| Tensile Strength (Before Aging) | ASTM D412 | Min 14.0 MPa | 32.35 MPa | Pass |
| Ultimate Elongation (Before Aging) | ASTM D412 | Min 500% | 568% | Pass |
| Tensile Strength (After Aging) | ASTM D412 | Min 14.0 MPa | 36.10 MPa | Pass |
| Ultimate Elongation (After Aging) | ASTM D412 | Min 400% | 551% | Pass |
| Length (Dimension) | ASTM D3767 | Min 240 mm | 249 mm | Pass |
| Width (Dimension) | ASTM D3767 | 95 ± 10 mm | 98 mm | Pass |
| Thickness - Finger (Dimension) | ASTM D3767 | Min 0.05 mm | 0.10 mm | Pass |
| Thickness - Palm (Dimension) | ASTM D3767 | Min 0.05 mm | 0.07 mm | Pass |
| Watertight | ASTM D5151 | AQL 1.5, Acceptance No. 10 for 315 samples | 0 pieces with leaks (for 315 samples) | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove | 0.24 mg per glove | Pass |
| Biocompatibility | ISO 10993-10:2010 (E) & Consumer Product Safety Commission Title 16. Chapter II, Part 1500 | Non-irritant and non-sensitizer | Negligible irritant response, no sensitization effect in guinea pigs | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 (E) | No systemic toxicity induced | No systemic toxicity induced | Pass |
2. Sample size used for the test set and the data provenance
- Physical Properties (Tensile Strength, Ultimate Elongation, Dimensions): The sample sizes are not explicitly stated for each specific test, but ASTM D412 and ASTM D3767 standards typically specify sample sizes for these types of tests.
- Watertight: The sample size used was 315 pieces (based on inspection level G1 for a batch size of 150,001 to 500,000 under AQL 1.5).
- Residual Powder: The sample size used was 5 pieces.
- Biocompatibility: The specific sample sizes for in vivo tests (like primary skin irritation, dermal sensitization, acute systemic toxicity) are not explicitly mentioned in terms of number of animals, but the standards (ISO 10993-10, ISO 10993-11) outline the appropriate sample sizes and methodologies for these studies.
- Data Provenance: The data is non-clinical test data conducted by Onetexx Sdn Bhd (Malaysia), indicated by the submitter's address. These are prospective tests performed on the device to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a patient examination glove, and its performance is assessed through standardized physical and chemical tests (e.g., tensile strength, watertightness, biocompatibility), not through expert interpretation of medical images or other data requiring "ground truth" established by human experts.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML performance studies, especially when human interpretation is involved. For physical and chemical testing of medical gloves, results are determined by adherence to established test procedures and measurement against quantitative 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
This question is not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device is established by objective measurements and standardized test procedures defined by ASTM and ISO standards (e.g., ASTM D412 for tensile properties, ASTM D5151 for watertightness, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for this product's performance evaluation.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/ML device, and therefore does not have a "training set."
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June 28, 2021
Onetexx SDN BHD % Michael Van der Woude U.S. Agent Emergo Global Representation 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746
Re: K210587
Trade/Device Name: Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 23, 2021 Received: June 1, 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 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,
Ryan Ortega 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210587
Device Name VIOLET NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, 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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Image /page/3/Picture/0 description: The image shows the word "onetexx" in a sans-serif font, with the letters in dark blue. To the right of the word is a circular logo in teal and dark blue. The logo is a circle with a square cut out of the upper right quadrant.
1.0 Submitter:
| Name: | Freddy Low |
|---|---|
| Address: | Onetexx Sdn BhdNo: 73-86, Jalan Logam 5, Perindustrian Kamunting 3,Kamunting Raya Industrial Estate, 34600 Kamunting, PerakDarul Ridzuan, Malaysia. |
| Phone No.: | +60 5 8070 666 |
| Fax No.: | +60 5 8070 666 |
Date of Summary Prepared: 27th May 2021
2.0 Identification of the subject device:
| Trade Name | : Violet Nitrile Powder Free Patient Examination Glove, NonSterile |
|---|---|
| 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:
K143289
Non-Sterile, Powder Free Nitrile Examination Gloves - Violet Color -LZA Company: YTY INDUSTRY (MANJUNG) SDN. BHD.
4.0 Description of The Device:
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from Nitrile 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.
Indication for use: 5.0
A patient examination glove is a disposable device made of Nitrile latex 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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Image /page/4/Picture/0 description: The image shows the logo for the company "onetexx". The word "onetexx" is written in a bold, sans-serif font and is colored in a dark blue. To the right of the word is a circular logo that is partially filled in with dark blue and light blue.
6.0 Summary of the Technological Characteristics of the Device:
The Violet Nitrile Powder Free Patient Examination Glove, 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 | COMPARISONANALYSIS | ||
|---|---|---|---|---|---|
| PREDICATEVIOLET | CURRENTVIOLET | ||||
| 510(k) Number | - | K143289 | K210587 | ||
| Manufacturer(s) | - | YTY Industry (Manjung) Sdn Bhd | Onetexx Sdn Bhd | Same | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same | |
| Color | - | Violet | Violet | Same | |
| Product Code | - | LZA | LZA | Same | |
| Physical Properties | ASTM D6319 | ||||
| Before Aging | |||||
| Tensile Strength: | 23.22-29.11Mpa | 32.35Mpa | Different but | ||
| Ultimate Elongation: | 520-580% | 568% | within the ASTMstandard | ||
| After Aging | |||||
| Tensile Strength: | 27.39-30.82 | 36.10Mpa | Different but | ||
| Ultimate Elongation: | 440-500% | 551% | within the ASTMstandard | ||
| Thickness: | ASTM D6319 | ||||
| - Finger | 0.09-0.11mm | 0.10mm | Different but | ||
| - Palm | 0.06-0.07mm | 0.07mm | within the ASTMstandard | ||
| - Finger | 0.05-0.06mm | Different butwithin the ASTMstandard | |||
| Length: | ASTM D6319 | 240 - 244mm | 246 - 255mm | Different butwithin the ASTMstandard | |
| Powder Free | ASTM D6124 | 0.14mg/glove | 0.24 mg/glove | Different butwithin the ASTMstandard |
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Image /page/6/Picture/0 description: The image shows the logo for "onetexx". The word "onetexx" is written in a dark blue sans-serif font. To the right of the word is a circular logo that is partially dark blue and partially light blue. The dark blue portion of the logo is in the shape of a square.
| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISONANALYSIS |
| VIOLET | VIOLET | |||
| Biocompatibility | Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500 | Under the condition of the studythe device is non-irritant andnon-sensitizer | Under the conditions of thisstudy the device 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 condition of the studythe device is non-irritant andnon-sensitizer | Under the conditions of thisstudy the device did notproduce a skin sensitizationeffect in the guinea pigs. | Similar | |
| Acute SystemicToxicity, ISO 10993-11:2017 (E) | Not Tested | Under conditions of this studythe device did not induce anysystemic toxicity. | Different |
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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISONANALYSIS | |
|---|---|---|---|---|
| PREDICATEVIOLET | CURRENTVIOLET | |||
| Watertight (1000ml) | ASTM D5151:2019 | AQL 2.5Result: 0 | Gloves passed AQL 1.5 | Different butwithin the ASTMstandard |
| Indication for Use | - | A patient examination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. | A patient examination glove is adisposable device made ofsynthetic rubber latex intendedfor medical purposes that isworn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Same |
| Size | Medical GloveGuidance Manual -Labeling | Medium | Extra SmallSmallMediumLargeExtra Large | Similar |
| Single use | Medical GloveGuidance Manual -Labeling | Single Use | Single Use | Same |
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Image /page/8/Picture/0 description: The image shows the onetexx logo. The word "onetexx" is written in a dark blue sans-serif font. To the right of the word is a circular logo in a light blue color with a dark blue square in the upper right quadrant.
There are no significant differences between the two products and are identical in terms of intended use, materials design, physical properties, color, thickness and biocompatibility.
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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| Acceptance Criteria | Results | |||||||
|---|---|---|---|---|---|---|---|---|
| TestMethod | Standard | Purpose of Testing | Beforeaging | Afteraging | Beforeaging | Afteraging | Status | |
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanized Rubber | To evaluate thetensile (tension)properties of glove. | Tensilestrength | Min 14.0MPa | Min 14.0MPa | 32.35Mpa | 36.10Mpa | Pass |
| and ThermoplasticElastomers-Tension) | Ultimateelongation | Min500% | Min400% | 568% | 551% | Pass |
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | Status | ||
|---|---|---|---|---|---|---|---|
| Dimension | ASTM D3767Standard Practice forRubber–Measurement ofDimensions | To measure thelength, width andthickness ofglove | Length | Min 240 mm | Length | 249 mm | Pass |
| Width | $95 \pm 10$ mm | Width | 98 mm | Pass | |||
| Thickness | Finger - min 0.05mm | Thickness | 0.10mm | Pass | |||
| Palm - min 0.05mm | 0.07mm |
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Image /page/10/Picture/0 description: The image shows the logo for "onetexx". The text "onetexx" is written in a dark blue sans-serif font. To the right of the text is a circular graphic that is partially filled in with dark blue and light blue.
| 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: 500 pcsInspection level: G1AQL: 1.5, Acceptance No. 10 | The batch size for thissampling is 150,001 to500,000. Hence,according to the singlesampling plan GI, thesample to be drawn isunder code Mequivalent to 315pieces with accept 10and reject 11 to beaccepted under AQL1.5. During the test, 0piece was found withleaks. Hence it fallswithin the acceptancecriteria. | Pass |
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Image /page/11/Picture/0 description: The image shows the onetexx logo. The word "onetexx" is written in a bold, sans-serif font. To the right of the word is a circular icon that is partially filled in with a darker color. The logo is simple and modern.
| 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:0.24mg/glove | Pass |
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Image /page/12/Picture/0 description: The image shows the logo for "onetexx". The word "onetexx" is written in a bold, sans-serif font in a dark color, likely black or a very dark shade of gray. To the right of the word "onetexx" is a stylized graphic element in a lighter color, possibly teal or cyan. The graphic element appears to be a partial or stylized representation of a circle or a "C" shape, with a portion of it filled in with a darker shade, creating a sense of depth or dimension.
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 Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K143289.
§ 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.