(25 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free , Poly, Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00a(2005).
The provided text describes a 510(k) submission for medical examination gloves and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about the performance of a diagnostic AI device or a study designed to evaluate its acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert ground truth, adjudication methods, or MRMC studies is not applicable to this document.
However, I can extract the acceptance criteria and documented performance for the medical device described (a glove), as well as details about the non-clinical tests performed.
Acceptance Criteria and Reported Device Performance (for the glove device)
| Acceptance Criteria / Test | Reported Device Performance / Compliance |
|---|---|
| Physical and Dimensions Testing (ASTM D-6319-00a(2005)) | All testing meets requirements; Inspection level S-2, AQL 4.0. |
| Pinhole Test (FDA 1000 ml. Water Fill Test) | Meets requirements; Samplings of AQL 2.5, inspection level G-1. Conforms fully to FDA pinhole requirements. |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Residual Powder Test (ASTM D-6124-06) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility Requirements | Meets biocompatibility requirements (as shown by data in Section 7). |
| Labeling Claims | Meets labeling claims; No special labeling claims are made, and gloves are not claimed as hypoallergenic. |
| Overall Conformity to Standards | Conforms fully to ASTM D-6319-00a(2005) standard as well as applicable 21 CFR references. No safety/efficacy issues or new claims from the "substantial equivalence" products cited. |
Study Information (Non-Clinical Tests for the Glove Device)
- Sample size used for the test set and the data provenance:
- Physical/Dimensions testing: Inspection level S-2, AQL 4.0. (Specific sample size not provided, but implies a statistical sampling plan based on AQL).
- Pinhole (Water Fill Test): AQL 2.5, inspection level G-1. (Specific sample size not provided, but implies a statistical sampling plan based on AQL).
- Primary Skin Irritation and Skin Sensitization: No details on sample size or provenance.
- Residual Powder Test: No details on sample size or provenance.
- Data Provenance: Not explicitly stated, but assumed to be from manufacturing runs of the Syntex Healthcare Products Co., Ltd. gloves.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical and chemical tests, not diagnostic interpretations.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a diagnostic AI device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable.
- The type of ground truth used:
- Physical/Dimensions Testing: Predetermined specifications outlined in ASTM D-6319-00a(2005).
- Pinhole Testing: Absence of water leakage under specific pressure/volume conditions per FDA 1000 ml Water Fill Test.
- Biocompatibility (Skin Irritation/Sensitization): Observation of skin reactions in test subjects to determine irritant or sensitizing properties.
- Residual Powder: Quantitative measurement of powder content against the 2 mg per glove limit specified in ASTM D-6124-06.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
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MAY 2 3 2006
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: __ kcCG | |92
1. Submitter's Identification:
Mr. Hao Jun Jie Syntex Healthcare Products Co., Ltd. No. 1 Fanjiazhuang Industrial Zone Xinji City, Hebei, China
Date Summary Prepared: April 22, 2006
2. Name of the Device:
Syntex Healthcare Products Co., Ltd. Blue Colour Powder Free BarrierPro Polymer® BP2000 polybutadiene Copolymer Examination Gloves
3. Predicate Device Information:
Perusahaan Getah Asas Sdn. Bhd. Powder-free Barrier-Pro™ Co-Polymer Examination Glove
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free , Poly, Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00a(2005).
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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6. Comparison to Predicate Devices:
Syntex Healthcare Products Co., Ltd.'s Blue Colour Powder Free BarrierPro Polymer® BP2000 polybutadiene Copolymer Examination Gloves is substantially equivalent in safety and effectiveness to the Perusahaan Getah Asas Sdn. Bhd.'s Powder-free Barrier-ProTM Co-Polymer Examination Glove
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Syntex Healthcare Products Co., Ltd.'s glove production are based on ASTM-D-6319-00a(2005). All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level G-1, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
A Residual Powder Test that based on ASTM D-6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
10. Conclusions:
Syntex Healthcare Products Co., Ltd.'s Blue Colour Powder Free BarrierPro Polymer® BP2000 polybutadiene Copolymer Examination Gloves conform fully to ASTM D-6319-00a(2005) 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2006
Syntex Healthcare Products Company, Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schafer Avenue Chino, California 91710
Re: K061192
Trade/Device Name: Blue Colour Powder Free BarrierPro Polymer® BP2000 Polybutadiene Copolymer Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: April 22, 2006 Received: May 1, 2006
Dear Ms. Liu:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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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Page 2 - Ms. Liu
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); 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 100Q-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A
t
INDICATIONS FOR USE
510(K) NUMBER APPLICANT: DEVICE NAME:
KOGI192 (IF KNOWN): Syntex Healthcare Products Co., Ltd.
Blue Colour Powder Free BarrierPro Polymer® BP2000 polybutadiene Copolymer Examination Gloves
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| concurrent of CDRH, Office of Device Evaluation (ODE) |
|---|
| 5/23/14 |
ociology, General Hospital,
Control, Lental Devices
§ 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.