(73 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.
Device Acceptance Criteria and Performance Study Analysis:
1. Table of Acceptance Criteria and Reported Device Performance:
| Description | Acceptance Criteria (from predicate "Substantially equivalent") | Reported Device Performance (Dehai Nitrile Examination Gloves) |
|---|---|---|
| Material | Substantially equivalent to predicate | Nitrile Latex (NBR), Sulfur, Accelerator (ZDBC), Zinc Oxide, Potassium Hydroxide, Titanium Dioxide, and Stabilizer. (Deemed substantially equivalent to predicate's materials) |
| Before Aging: Tensile Strength (Mpa) | Substantially equivalent to predicate | 29.00 Mpa |
| Before Aging: Ultimate Elongations (%) | Substantially equivalent to predicate | 750% |
| After Aging: Tensile Strength (Mpa) | Substantially equivalent to predicate | 24.00 Mpa |
| After Aging: Ultimate Elongations (%) | Substantially equivalent to predicate | 700% |
| Overall Length on Medium Size (mm) | Substantially equivalent to predicate | Average over 230mm |
| Width of Palm on Medium Size (mm) | Substantially equivalent to predicate | Average 95mm |
| Film Thickness (mm) | Substantially equivalent to predicate | Average 0.073 mm |
| Finger Thickness (mm) | Substantially equivalent to predicate | Average 0.090 mm |
| Residual Powder (mg/glove) | Substantially equivalent to predicate (no more than 2 mg powder per glove based on ASTM D6124-06) | < 2 mg per glove, with no defective gloves found according to ASTM D6124-06. |
| Pinhole Results | Substantially equivalent to predicate (AQL 2.5) | Less than two defective gloves out of 125 pieces tested according to ASTM D5151-06. AQL 2.5 is met. |
| Biocompatibility: Primary Skin Irritation | Substantially equivalent to predicate (passes ISO 10993-10) | Passes ISO 10993-10 |
| Biocompatibility: Dermal Sensitization (Allergic Contact Dermatitis) | Substantially equivalent to predicate (passes ISO 10993-10) | Passes ISO 10993-10 |
Study Proving Device Meets Acceptance Criteria:
The study to prove the device met acceptance criteria was a comparison to a predicate device (K082598), Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free. The subject device, Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Examination Gloves - Powder Free, Blue Color, was asserted to be "substantially equivalent" in all technological characteristics to the predicate device.
The study involved non-clinical tests based on ASTM-D-6319-10 for physical and dimensions testing, and the FDA 1000 ml. Water Fill Test for pinhole detection. Additionally, biocompatibility testing (Primary Skin Irritation and Skin Sensitization) was conducted based on ISO 10993-10.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Pinhole Testing (Water Fill Test): AQL 2.5, Inspection Level I, sampling of 125 pieces (gloves were found to have less than two pinholes out of 125).
- Physical and Dimensions Testing (Tensile Strength, Elongation, Length, Width, Thickness): Inspection Level S-2 AQL 2.5. The specific sample size for each test within this category is not explicitly stated beyond "samplings of AQL 2.5."
- Residual Powder: According to ASTM D6124-06. The specific sample size is not explicitly stated.
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not explicitly stated, but testing was conducted with results showing no primary skin irritant or sensitizing reactions.
Data Provenance: The data appears to be prospective as these tests were conducted on the subject device by the manufacturer (Dehai (Shandong) Medical Gloves, Co., Ltd.) to demonstrate substantial equivalence to the predicate device. The country of origin of the data is China, where the manufacturing company is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for this type of medical device (examination gloves). The ground truth is established by standardized testing protocols (ASTM, ISO, FDA Water Fill Test) and comparisons against predefined criteria or a predicate device's characteristics. There's no indication of human expert interpretation for physical or chemical properties of the gloves.
4. Adjudication Method for the Test Set:
Not applicable. This type of device evaluation (physical and chemical properties of gloves) does not typically involve human adjudication in the way medical imaging or diagnostic devices might. Results are obtained directly from standardized tests and compared against numerical criteria or the properties of the predicate device.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This type of study focuses on the effectiveness of human readers, typically in interpreting medical images or diagnostic information, which is not relevant for the evaluation of examination gloves.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This device is a physical medical glove, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for its evaluation.
7. Type of Ground Truth Used:
The ground truth used is primarily standardized test results and direct measurement data compared to established industry standards (ASTM-D-6319-10, ASTM D6124-06, ASTM D5151-06, ISO 10993-10) and the characteristics of a predicate device. It's a "pass/fail" or "meets specification" type of ground truth based on objective measurements rather than expert consensus on a diagnostic outcome or pathology.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."
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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FEB 2 8 2013
510 (K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
1. Submitter's Identification:
Dehai (Shandong) Medical Gloves, Co., Ltd. No. 216 Huangong Road Linzi District, Zibo, Shandong China
Contact Person: Ray Zhou Tel: 909-548-4828 Fax: 909-548-4807 Email: rayzhou@basicmedical.com
Date summary prepared: Feb. 5, 2013
2. Name of the Device:
Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Examination Gloves - Powder Free, Blue Color
3. Predicate Device Information:
Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free (K082598)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.
ડ. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
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6. Comparison to Predicate Devices:
Dehai (Shandong) Medical Gloves, Co., Ltd. powder-free nitrile examination gloves (subject device) and Tangshan Zhonghong Pulin Group Co., Ltd. powder-free nitrile examination glove (predicate device) are substantially equivalent in all technological characteristics, including tensile steength, p ultimate elongations size, thickness, residual powder and pinhole. (please kindly refer attached side-by-side comparison of intended use, design, material, physical, biocompatibility and performance testing, Table 7-2)
Discussion of Non-Clinical tests performed for Determination of 7. Substantial Equivalence are as follows:
The standards used for Dehai (Shandong) Medical Gloves, Co., Ltd. glove production are based on ASTM-D-6319-10. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Lewell S-2 AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitize toa reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Patient Examination Gloves, Powder-Free, Blue color, conform fully to ASTM-D-6319-10 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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Side-by-Side Comparison of Intended Use, Design, Material, Biocompatibility, and Performance Testing Table 7-2.
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| Description | Proposed Device | Predicate Device (K082598) |
|---|---|---|
| Dehai (Shandong) Medical Gloves, Co., Ltd.Powder-Free Nitrile Examination Gloves, Blue color | Tangshan Zhonghong Pulin GroupCo., Ltd. Powder Free Nitrile PatientExamination Gloves | |
| Labeling: Instructionfor use | A garment covering the hand and wrist area.Clovers have separate sheaths or openings foreach finger and the thumb. | Substantially equivalent |
| Labeling: Labels onthe carton | Labels include: Product name; color; "singleuse Only" size, piece count, lot number,distributor name, and manufacturer address. | Substantially equivalent |
| Device Materials | Nitrile Latex (NBR)SulfurAccelerator, ZDBCZinc OxidePotassium HydroxideTitanium Dioxide and Stabilizer | Substantially equivalent |
| Before Aging: TensileStrength(Mpa) andUltimate Elongations | Average Tensile Strength (Mpa): 29.00Average Ultimate Elongations: 750% | Substantially equivalent |
| After Aging: TensileStrength(Mpa) andUltimate Elongations | Average Tensile Strength (Mpa): 24.00Average Ultimate Elongations: 700% | Substantially equivalent |
| Overall Length onMedium Size | Average over 230mm | Substantially equivalent |
| Width of Palm onMedium Size | Average 95mm | Substantially equivalent |
| Film Thickness | Average 0.073 mm | Substantially equivalent |
| Figure Thickness | Average 0.090 mm | Substantially equivalent |
| Residual Powder | According to ASTM D6124-06 Standard TestMethod for Residual Powder on Medical glovesfor the determination of residual powdercontent. Testing result indicates the weight ofall types of residual or powder on finishedpowder-free gloves as <2 mg per glove andthere is no defect glove found according toASTM D6124-06. | Substantially equivalent |
| Pinhole Results | According to ASTM D5151-06, Testing resultindicates pinhole were found less than twopieces gloves out of 125 pieces gloves. AQL2.5 is met. | Substantially equivalent |
| Biocompatibilityresult: Primary SkinIrritation | ISO 10993-10 passes | Substantially equivalent |
| Dermal Sensitization | ISO 10993-10 passes | Substantially equivalent |
| Summary ofComparison | Dehai (Shandong) Medical Gloves, Co., Ltd. powder-free nitrile examination gloves(subject device) and Tangshan Zhonghong Pulin Group Co., Ltd. powder-free nitrileexamination glove (predicate device) are substantially equivalent in all technologicalcharacteristics, including tensile strength, ultimate elongations size, thickness, residualpowder and pinhole. | Substantially equivalent |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
Dehai (Shandong) Medical Gloves, Company, Limited C/O Mr. Ray Zhou President Basic Medical Industries, Incorporated 12390 East End Avenue CHINO CA 91710
Re: K123869
Trade/Device Name: Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 10, 2012 Received: December 17, 2012
Dear Mr. Zhou:
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 iddications 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 The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding and adulteration. Please note: CDRH does not evaluate information related to contract lightlity warranties. We remind you; however; that device labeling must be truthful and not minley
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 devil { in it}, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Dehai (Shandong) Medical Gloves, Co., Ltd.
No. 216 Huangong Road, Linzi District, Zibo, Shandong, China Tel: 8618905331363
INDICATIONS FOR USE
Dehai (Shandong) Medical Gloves, Co., Ltd. Applicant:
1123869 510(k) Number:
Device Name: Patient Nitrile Examination Gloves, Powder free, Non-Sterile, Blue Color .
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use.
Over the Counter Use
Factory Initials
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510(k) Number: K123864
§ 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.