(48 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 a 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 Nitrile Examination Gloves, Blue, 80 LZA, and meets all requirements of ASTM standard D-6319-00a (2005).
The provided text describes the 510(k) summary for the Hong Xin Rubber Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue. This document is a premarket notification for a Class I medical device, which is typically a low-risk device. For such devices, clinical studies and complex performance evaluations, as you've outlined, are generally not required. Instead, the focus is on demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards.
Therefore, many of the requested sections (2-9) are not applicable to this type of submission.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D-6319-00a (2005) - Physical and Dimensions Testing (Inspection level S-2, AQL 4.0) | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| FDA 1000 ml. Water Fill Test (AQL 2.5, inspection level G-1) | "meeting these requirements." (Implies meeting pinhole requirements) |
| Primary Skin Irritation Testing | "results showing no primary skin irritant or sensitization reactions." |
| Skin Sensitization (allergic contact dermatitis) Testing | "results showing no primary skin irritant or sensitization reactions." |
| ASTM D-6124-06 - Residual Powder Test (for "powder-free" claim: ≤ 2 mg powder per glove) | "our gloves meet our “powder-free” claims (contain no more than 2 mg powder per glove)." |
| Biocompatibility Requirements (not explicitly detailed, but stated as met) | "meets biocompatibility requirements" |
| Applicable 21 CFR references (not explicitly detailed, but stated as met) | "conform fully to... applicable 21 CFR references" |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing (ASTM D-6319-00a): Inspection level S-2, AQL 4.0. The exact sample size is not stated but is determined by the AQL (Acceptable Quality Level) and inspection level for lot sizes as defined in the ASTM standard.
- FDA 1000 ml. Water Fill Test: Inspection level G-1, AQL 2.5. The exact sample size is not stated but is determined by the AQL and inspection level for lot sizes.
- Primary Skin Irritation and Skin Sensitization Testing: Not specified.
- Residual Powder Test (ASTM D-6124-06): Not specified.
- Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by Hong Xin Plastic Products Co., Ltd. within China. This is a retrospective analysis of manufacturing quality control data and specific biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is established by objective engineering and chemical standards, not expert clinical interpretation.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements and pass/fail criteria against established standards, not subjective adjudication.
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 is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used
The ground truth used for this device is based on recognized industry standards (ASTM) and regulatory requirements (FDA pinhole test, 21 CFR). This includes:
- Defined specifications for physical properties (e.g., dimensions, tensile strength).
- Objective measurement criteria for defect levels (AQL for pinholes).
- Established procedures for biocompatibility (skin irritation and sensitization).
- Quantifiable limits for residual powder.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set." Performance is based on manufacturing quality control and specific material testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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510(K) SUMMARY
MAY 15 2007
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: ___
1. Submitter's Identification:
Mr. Yuchun Jia Hong xin Plastic Products Co., Ltd. Fanjiazhuang Industrial Zone Xinji City, Hebei, China 052360
Date Summary Prepared: December 28, 2006
2. Name of the Device:
Hong Xin Rubber Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue
3. Predicate Device Information:
Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Exam Gloves, Powder-Free, Color Blue (K001128)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Examination Gloves, Blue, 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:
Hong Xin Rubber Products Co., Ltd.'s Powder Free Nitrile Examination Gloves, Blue, is substantially equivalent in safety and effectiveness to the Shanghai Poseidon Plastic Products Co., Ltd.'s Nitrile Exam Gloves, Powder-Free, Color Blue.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Hong Xin Rubber 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:
Hong Xin Rubber Products Co., Ltd.'s Powder Free Nitrile Examination Gloves, Blue 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, graphic style.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Hong Xin Rubber Products Company Limited C/O Ms. Kathy Liu Official Correspondent Gloveco Incorporated 3973 Schafer Avenue Chino, California 91710
MAY 15 2007
Re: K070861
Trade/Device Name: Power Free Nitrile Examination Gloves, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 28, 2006 Received: March 28, 2007
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 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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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 1000-1050.
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 your 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
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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INDICATION FOR USE
510(K) NUMBER (IF KNOWN): APPLICANT: DEVICE NAME:
Hong Xin Rubber Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical a 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
(K) Number __
Over-The-Counter-Use V
(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)
K070861
sign-Off)
ion of Anesthesiology, General Hospital,
suon Control, Dental 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.