(157 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 Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides two tables that fulfill this request:
- A "Technology Characteristic Comparison between the device and predicate device" table on page 4-5.
- A "Non-clinical Testing Summary" table on page 6.
Let's combine and summarize the relevant information from both into a single table for clarity. Note that some "acceptance criteria" are simply the standard reference, and the "reported device performance" indicates "Complied with the standard". For detailed numerical values, refer to the "Technology Characteristic Comparison" table.
| Characteristic / Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | LYY | LYY |
| Intended Use | Prevent contamination between patient and examiner. | Same as predicate. |
| Classification | Class I | Class I |
| Raw Rubber Material | Natural Rubber Latex | Natural Rubber Latex |
| Color | No color pigment added. Natural White | No color pigment added. Natural White |
| Overall Length Minimum | 230mm (Predicate: Meet ASTM D3578-05) | Average: 247 mm |
| Width (S, M, L) | S: 75-95mm; M: 85-105mm; L: 100-120mm | S: 85mm; M: 96 mm; L: 104 mm |
| Palm Thickness (Minimum) | 0.08mm | Average: 0.122 mm |
| Finger Thickness (Minimum) | 0.08mm | Average: 0.156 mm |
| Tensile Strength (before age) | Minimum 18 MPa | Average: 26.17MPa |
| Tensile Strength (After Age) | Minimum 14 MPa | Average: 24.82MPa |
| Stress at 500% Elongation | Maximum 5.5 MPa | 4.99 MPa |
| Ultimate Elongation (before age) | Minimum 500% | Average: 759.85% |
| Ultimate Elongation (after age) | Minimum 400% | Average: 678.62% |
| Freedom of Holes | Meet AQL 2.5 at G1 | Meet AQL 2.5 with G1 (Also Complied with ASTM D5151-06) |
| Residual powder test | Less than 2mg/glove | S: 0.43 mg/glove; M: 0.31 mg/glove; L: 0.47 mg/glove (Complied with ASTM D6124-06) |
| Protein Testing | Less than 50 µg/dm2 | S, M, L sizes: Less than 50 µg/dm2 |
| Primary Skin Irritation | Not an irritant (ISO 10993-10:2010) | Not an irritant |
| Dermal Sensitization | Not a sensitizer (ISO 10993-10:2010) | Not a sensitizer |
| Acute Systemic Toxicity | No evidence of systemic toxicity (from extract) | No evidence of systemic toxicity |
| Overall Compliance | Various ASTM and ISO standards | Complied with relevant standards (ASTM D6124-06, ASTM D5151-06, ASTM D3578-19, ISO 10993-10:2010) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for Freedom of Holes, or how many individuals for skin irritation). It only reports the average values or compliance statements.
The data provenance is not explicitly stated as retrospective or prospective for the non-clinical tests. The company, Shandong Intco Medical Products Co, Ltd, is located in China, suggesting the testing likely occurred there or was commissioned by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of device and testing described. The device is a "Latex Examination Glove," and its performance is evaluated through physical, chemical, and biological non-clinical tests based on established international standards (ASTM, ISO). Expert interpretation of medical images or diagnoses is not involved in establishing the "ground truth" for glove performance. The "ground truth" here refers to the measured physical and chemical properties and biological reactions as defined by the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the testing involves non-clinical measurements against predefined standard specifications, not a subjective interpretation requiring adjudication by multiple experts.
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 device is a medical glove, not an AI-assisted diagnostic tool or system that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical product (medical glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for evaluating the Latex Examination Gloves is based on established international and national standards and specifications for medical gloves. This includes:
- ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties.
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
- ASTM D5151-06 (Reapproved 2015) (Standard Test Method for Detection of Holes in Medical Gloves) for freedom of holes.
- ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) for biocompatibility.
The "ground truth" is therefore the objective measurement of the glove's characteristics against these well-defined and accepted standard limits.
8. The sample size for the training set
Not applicable. The device is a physical medical product, not an AI/ML algorithm that requires a training set. The performance data is from non-clinical testing of the manufactured product.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 8, 2022
Shandong Intco Medical Products Co, Ltd. % John Zhao Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave. Ontario, California 91764
Re: K213509
Trade/Device Name: Latex Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: March 8, 2022 Received: March 9, 2022
Dear John Zhao:
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,
Clarence W. Murray, III, PhD 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) K213509
Device Name Powder Free Latex Examination Glove
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 logo for Shandong Intco Medical Products Co., Ltd. The logo includes a stylized blue graphic to the left of the company name. Below the company name is the address: 9888 Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, 262500.
510(K) SUMMARY
1. Submitter's Identification:
Shandong Intco Medical Products Co, Itd. 9888 Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, 262500 China
Contact Person :
Haisheng Yu Vice General Manager
Date summary prepared: Oct. 28, 2021
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- Product Trade Name: Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free
-
- Device Classification Name: Patient Examination gloves (21 CFR 880.6250)
- Device Class: 4. Class I.
- Product Code: 5. LYY
- Predicate Devices: 6. K161833 – Careglove Global SDN BHD
7. Reason for 510(k) Submission:
New device.
8. Device Description:
Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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9. Intended Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
10. Technology Characteristic Comparison between the device and predicate device:
There is no difference in technology characteristic compared to the predicate device. Gloves are made from natural rubber latex compound. Non-Sterile, Powder Free Latex Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.
| Characteristicsand Parameters | Powder FreeLatexExaminationGlove | Powder FreeLatexExaminationGlove (K161833) | Comparison |
|---|---|---|---|
| Product Code | LYY | LYY | Same |
| Intended Use | A patientexamination gloveis a disposabledevice intendedfor medicalpurposes that isworn on the handor finger topreventcontaminationbetween patientand examiner. | A patientexamination gloveis a disposabledevice intended formedical purposesthat is worn on thehand or finger topreventcontaminationbetween patient andexaminer. | Same |
| Classification | Class I | Class I | Same |
| Raw RubberMaterial | Natural RubberLatex | Natural RubberLatex | Same |
| Color | No color pigmentadded. NaturalWhite | No color pigmentadded.NaturalWhite | Similar |
| Overall LengthMinimum230mm | Average: 247 mm | Meet ASTM D3578-05 | Similar |
| WidthS: 75mm - 95mm; M: 85mm –105mm; L:100mm- 120mm | Average:S: 85mmM:96 mmL:104 mm: | S: 82mm - 87 mm M:94mm - 97mm L: 102mm -107mm | Similar |
| Palm Thickness (Minimum | Average: 0.122 mm | 0.12mm - 0.14 mm | Similar |
| 0.08mm) | |||
| Finger Thickness (Minimum | Average:0.156 mm | 0.10 - 0.13 mm | Similar |
| 0.08mm) | |||
| Tensile Strength (before age)Minimum 18 MPa | Average: 26.17MPa | 21.18 - 26.17 MPa | Similar |
| Tensile Strength (After Age)Minimum 14 MPa | Average: 24.82MPa | 18.28 - 23.88 MPa | Similar |
| Stress at 500% Elongation 5.5 MPaMaximum | 4.99 MPa | 3.0 - 4.2 MPa | Similar |
| Ultimate Elongation before age(Minimum 500%) | Average: 759.85% | 750.20% - 820.20% | Similar |
| Ultimate Elongation after age(Minimum 400%) | Average: 678.62% | 550.40% - 700.50% | Similar |
| Freedom of HolesMeet AQL 2.5 at G1 | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1. | Similar |
| Residual powder test | Average powderresidue for eachsize: | Contained less than 2 mg/glove | Similar |
| (Less than 2mg/glove) | S: 0.43 mg/glove;M 0.31 mg/glove;L: 0.47 mg/glove | ||
| Protein Testing | S size: Less than 50µg/dm2; M size: Lessthan 50 µg/dm2; L size:Less than 50 µg/dm2 | less than 50 µg/dm2 | Similar |
| Primary Skin Irritation | Under the conditions ofstudy, not an irritant | Under the conditions of study,not an irritant | Same |
| Dermal Sensitization | Under the conditionsof study, not a sensitizer. | Under the conditions of study,not a sensitizer. | Same |
| Acute Systemic Toxicity | Under the conditions ofthe study, no evidenceof systemic toxicityfrom the extract | Not available | Different |
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11. Non-clinical Testing Summary:
Provided below is a summary of the standards and the test methodology that the subject device met the specification and acceptance criteria of the subject device.
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Biological Evaluationof Medical Devices -Part 10 | Tests For Irritation AndSkin Sensitization. | ISO 10993-10:2010 | Complied with thestandard |
| ASTM D6124-06(Reapproved 2017) | Standard Test Method forResidual Powder onMedical Gloves | ASTM D6124-06 | Complied with thestandard |
| ASTM D5151-06(Reapproved2015) | Standard Test Method forDetection of Holes inMedical Gloves. | ASTM D5151-06 | Complied with thestandard |
| ASTM D3578 - 19 | Standard Specification forRubber ExaminationGloves | ASTM D3578 - 19 | Complied with thestandard |
12. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that Shandong Intco Medical Products Co., Ltd. Powder Free, Latex Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.