(149 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners
The Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free, clear and are made of poly vinyl chloride. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.
The provided document is a 510(k) Premarket Notification for Powder-Free Clear Vinyl Patient Examination Gloves (K190095). This document is a submission to the FDA (Food and Drug Administration) for a Class I medical device. For such devices, the primary demonstration of meeting acceptance criteria relies on adhering to recognized performance standards and biocompatibility tests.
The document does not describe an AI medical device or a study involving human readers and AI assistance. Therefore, information related to AI-specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) is not applicable and is not present in the document.
Instead, the acceptance criteria and performance data pertain to the physical and biological properties of the examination gloves.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance for Powder-Free Clear Vinyl Patient Examination Gloves (K190095)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (K190095) | Comparison to Predicate Device (K022091) |
|---|---|---|
| ASTM D5250-06 (Poly Vinyl Chloride Gloves for Medical Applications) | ||
| Before Aging: | ||
| Tensile Strength (Mpa) | Average 17.44 Mpa | Predicate: Average 17.00 Mpa (Similar) |
| Ultimate Elongations (%) | Average 519.4% | Predicate: Average 500% (Similar) |
| After Aging: | ||
| Tensile Strength (Mpa) | Average 15 Mpa | Predicate: Average 15 Mpa (Similar) |
| Ultimate Elongations (%) | Average 481.96% | Predicate: Average 450% (Similar) |
| Overall Length (Medium Size) | Average 232.23 mm | Predicate: Average 232.23 mm (Same) |
| Width of Palm (Medium Size) | Average 95.08 mm | Predicate: Average 95.08 mm (Same) |
| Palm Thickness | Average 0.095 mm | Predicate: Average 0.095 mm (Same) |
| Finger Thickness | Average 0.090 mm | Predicate: Average 0.090 mm (Same) |
| ASTM D6124-06 (Residual Powder and Non-powder Solids on Medical Gloves) | ||
| Residual powder < 2 mg per glove | Met (Found 2 mg/glove) | Predicate: Met (< 2 mg per glove) (Same) |
| ASTM D5151-06 (Detection of Holes in Medical Gloves) | ||
| AQL 2.5 (Acceptable Quality Level) | Met (2 out of 125 gloves leaked) | Predicate: Met (2 out of 125 gloves leaked) (Same) |
| ISO 10993-10:2010 (Biological Evaluation - Irritation and Skin Sensitization) | ||
| No skin irritation in white rabbit model | Met (Not an irritant in the white rabbit model) | Predicate: Met (Not an irritant in the white rabbit model) (Same) |
| No skin sensitization in guinea pig model | Met (Not a sensitizer in the Guinea pig model) | Predicate: Met (Not a sensitizer in the Guinea pig model) (Same) |
| ISO 10993-5:2009 (Biological Evaluation - Cytotoxicity) | ||
| Percent cytotoxicity not > 30% | Met (Device extract not cytotoxic to mammalian cell culture - mouse fibroblasts L929 cells) | Predicate: N/A (Note: The predicate device submission (K022091) did not explicitly list cytotoxicity testing in this comparison table, indicating "Different" in the comparison column for this specific test. However, the proposed device conducted and passed this test, adding to its safety profile.) |
2. Sample Size Used for the Test Set and Data Provenance:
- ASTM D5151-06 (Pinhole/Water Leak Test): 125 gloves were tested for the AQL (Acceptable Quality Level) 2.5 sampling.
- Other standards (e.g., ASTM 5250-06 for physical properties, ASTM D6124-06 for residual powder, ISO 10993 series for biocompatibility): Specific sample sizes for these tests are not explicitly stated within the provided text, but industry standards dictate typical sample sizes for such evaluations.
- Data Provenance: The manufacturer is Anhui Intco Medical Products Co., Ltd., located in Anhui Province, China. The testing was conducted by the manufacturer to demonstrate compliance with international standards. The data is retrospective, generated for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This document pertains to the physical and biological testing of a medical device (examination gloves), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" here is established by the validated methodologies of the ASTM and ISO standards themselves.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a submission for a Class I medical device based on performance standards and biocompatibility, there is no "adjudication" in the sense of expert consensus on image interpretation. The results are quantitative and objective measurements against established standard criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not relevant for the type of device (examination gloves) and the nature of the 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- The ground truth is based on validated methodologies and acceptance criteria defined by international standards such as ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards outline the methods for objectively measuring physical properties (e.g., tensile strength, elongation, dimensions, powder residue, pinholes) and biological responses (e.g., irritation, sensitization, cytotoxicity).
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
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June 20, 2019
Anhui Intco Medical Products Co. Ltd % Derek Tian Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave Ontario. California 91764
Re: K190095
Trade/Device Name: Powder-Free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: March 21, 2019 Received: March 26, 2019
Dear Derek Tian:
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.
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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 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 Elizabeth Claverie, M.S. THT4B2: Disinfection, Reprocessing and Personal Protection Acting Assistant Director, THT4B1: Sterility Devices 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)
Device Name
Powder-free clear vinyl patient examination gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners
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 contains a logo with the text "INTCO" in blue, with a stylized blue graphic above it resembling a flower or sunburst. Below "INTCO" are smaller Chinese characters. To the right, the text "Anhui Intco Med" is written in bold, black letters. The overall design appears to represent a company or organization, possibly in the medical field, based in Anhui.
Anhui Intco Medical Products Co,Itd
No. 1 Haitang Road, Suixi District economic development area, Huaibei City, Anhui Province
510(k) SUMMARY
K190095
This summary of 510(k) is being submitted in accordance 21 CFR §807.92.
Date summary prepared: June 19, 2019
1. Submitter's Identification:
Anhui Intco Medical Products Co, Ltd. No.1 Haitang Road, Suixi District economic development area Huaibei City, Anhui Province China
Contact Person
Jacken Cai Product Manager Tel: 86-13853653818 Email: jackencai@intco.com
US Representative Contact Person
Dongqi Tian Tel: 909-980-1678 Email: Tian.Dongqi@hotmail.com
-
- Name of the Device: Powder-free Clear Vinyl Patient Examination Gloves
-
- Common Name: Patient Examination Gloves
-
- Regulation number: 21 CFR 880.6250
-
- Class: I
- Product Code: LYZ 6.
-
- Predicate Device Information:
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Device name: Vinyl Examination Gloves, Powder-Free, Clear 510(k) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd
8. Device Description:
The Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free, clear and are made of poly vinyl chloride. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.
9. Indication for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patients and examiners.
10. Technological Characteristics
Side by side comparison (including technological characteristics) between subject and predicate device
| Proposed Device(K190095) | Predicate Device(K022091) | ComparisonConclusions | |
|---|---|---|---|
| Device Name | Powder-free ClearVinyl PatientExamination Gloves | Vinyl ExaminationGloves, Powder-Free,Clear | Similar |
| Manufacturer | Anhui Intco MedicalProducts Co, Itd. | Tangshan ZhonghongPulin Food ProductsCo., Ltd. | Different |
| Indication for use | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn upon theexaminer's hands orfingers to preventcontaminationbetween patients andexaminers. | A Vinyl patientexamination glove is adisposable deviceintended for medicalpurposes worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Same |
| Labeling: Labels onthe carton | Face: Proprietaryname, common name,contents size, lotnumber, distributed bySide: Proprietaryname, Indications forUse contents, size, lotnumber, distributedby, country andinstruction forstorage" Store in acool and dry place.Avoid Direct sunlight | N/A | Different |
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| Labels on thedispenser glove | Face: Powder-freeClear Vinyl PatientExamination Gloves,non-sterile, single useonly, contents: 100gloves (by weight) size,manufactured for:Intco MedicalIndustries, Inc. orother importers.Side: Powder-freeClear Vinyl PatientExamination Gloves,non-sterile, single useonly Contents: 100gloves (by weight),size, lot number,distributed by:Manufactured for: | Face: Vinylexamination GlovePowder-free,Contents: 100 gloves(by weight) Size: <Distributed by: Baldursystems Corp.Hayward, CA 94545Side: VinylExamination GlovePowder-free/SingleUse/Non-sterile,Content: 100 gloves(by weight) Size, madein China, Lot number | Similar | ||
|---|---|---|---|---|---|
| Device Materials | Poly Vinyl Chloride | Poly Vinyl Chloride | Similar | ||
| Color | Clear | Clear | Same | ||
| TechnologicalCharacteristics asper ASTM 5250-06(Reapproved2011) (FDArecognition #:6-183)StandardSpecification forPoly (VinylChloride) Glovesfor MedicalApplications | Before Aging:TensileStrength(Mpa)and UltimateElongationsAfter Aging:TensileStrength(Mpa)and UltimateElongationsAvailable Sizes | Average TensileStrength (Mpa): 17.44Average UltimateElongations: 519.4%Average TensileStrength (Mpa): 15Average UltimateElongations: 481.96%S, M, L, XL | Average TensileStrength (Mpa): 17.00Average UltimateElongations: 500%Average TensileStrength (Mpa): 15Average UltimateElongations: 450%S, M, L, XL | SimilarSimilarSame | |
| Overall Lengthon Medium SizeWidth of Palmon Medium SizePalm ThicknessFinger Thickness | Average over232.23mmAverage 95.08mmAverage 0.095 mmAverage 0.090 mm | Average over232.23mmAverage 95.08mmAverage 0.095 mmAverage 0.090 mm | SameSameSameSame | ||
| Residual PowderASTM D6124-06of residual or powder on finishedpowder-free gloves as < 2 mg perglove. | Meets ASTM D6124-06Residual powder onfinished powder-freegloves was < 2 mg perglove | Meets ASTM D6124-06Residual powder onfinished powder-freegloves was < 2 mg perglove | Same | ||
| Pinhole /Water Leak TestAccording to ASTM D5151-06,(Reapproved 2011)Sample 4, AQL 2.5 | Meets ASTM D5151-06According to ASTMD5151-06. Testingresult indicatedpinhole were found intwo gloves out of 125gloves examined. AQL2.5 . Criteria was met | Meets ASTM D5151-06According to ASTMD5151-06. Testingresult indicatedpinhole were foundtwo gloves out of 125gloves. AQL 2.5 wasmet. | Same | ||
| -Biocompatibility | Primary SkinIrritationISO 10993-10:2010ISO SkinIrritation Study | Under the conditionsof the study, the testmaterial was not anirritant in the whiterabbit model. | Under the conditionsof the study, the testmaterial was not anirritant in the whiterabbit model. | Same | |
| DermalSensitizationISO 10993-10:2010ISO Skin DermalSensitization | Under the conditionsof the study, an extractof this test materialwas not a sensitizer inthe Guinea pig model. | Under the conditionsof the study, an extractof this test materialwas not a sensitizer inthe Guinea pig model. | Same | ||
| CytotoxicityISO 10993-5:2009BiologicalEvaluation ofMedical Devices-Part 5: Test ForIn VitroCytotoxicity.Acceptancecriteria : Cellstreated withneat extractfrom testedarticle are notlysed | Under conditions ofthe study, the deviceextract is not cytotoxicto the mammalian cellculture (mousefibroblasts L929 cells) | N/A | Different |
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11. Summary of Non-Clinical Performance Data
The subject device was tested using the methodologies recommended in the following standards and the results met the acceptance criteria in the standards:
i) ASTM 5250-06 (Reapproved 2011) (FDA recognition # 6-183) Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Applications Acceptance Criteria: Length: ≥ 230 mm (min) Width (size Medium): 90-100 mm Thickness Finger 0.05 mm (min) Thickness Palm 0.08 mm (min) The subject device testing results meets all acceptance criteria.
ii) ASTM D5151-06 (FDA recognition #: 6-175) Standard Test for Detection of Holes in Medical Gloves Standard acceptance criteria: Results: Meets ASTM D5151-06 Sampling -4 AQL 2.5 of 125 gloves tested, 2 gloves were found to leak.
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iii) ASTM D6124-06 (FDA recognition #: 6-178) Standard Test Method to Determine the Amount of Residual Powder and Non-powder Solids on Medical Gloves.
Standard acceptance criteria: Powder residue < 2 g per glove Results: Meets ASTM D6124-06. We found that our gloves had 2 mg/glove of residual powder.
iv) ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: test for Irritation and Skin sensitization.Standard acceptance criteria: No skin irritation in the white rabbit model and no skin sensitization in the guinea pig model.
Results: Meets ISO 10993-10:2010
Skin Irritation: Under the condition of the test, the device extracts were not an irritant.
Skin Sensitization: Under the condition of the test, the device extracts were not a sensitizer.
v) ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Test for in vitro Cytotoxicity
Standard acceptance criteria: The percent of cytotoxicity should not be greater than 30% when cells are exposed to neat test article extract.
Results: Under the condition of the test, the neat extracts was not cytotoxicity
12. Summary of Clinical Performance Data
NA
13. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device (K190095) is as safe. as effective, and performs as well as or better than the legally marketed predicate device (K022091).
§ 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.