(63 days)
Powdered vinyl 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.
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Here's a breakdown of the acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)" based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from Pinhole | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | < 10 mg/dm² |
| Biocompatibility: | ||
| - Primary Skin Irritation | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| - Dermal Sensitization | Dermal sensitization in the guinea pig | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for testing each characteristic. However, it indicates compliance with recognized standards (ASTM D 5250-06, 21 CFR 800.20, ASTM D6124-01, and 15010993-10). These standards would specify the required sample sizes for each test.
The data provenance is from the manufacturer, Langfang Huilong Plastic Product Co., Ltd. in China. The data appears to be prospective testing conducted by the manufacturer to demonstrate compliance with the referenced standards for their specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For device testing that relies on recognized standards, the "ground truth" is typically established by the criteria outlined within those standards and evaluated by trained technicians or laboratories following the standard's methodologies. There isn't an explicit mention of "experts" in the context of establishing a ground truth for individual test sets, as one might find in clinical image analysis studies.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly those involving human readers or subjective interpretations of data, to resolve discrepancies or establish a consensus diagnosis. For compliance testing of medical devices like gloves, results are typically objective measurements against defined pass/fail criteria per the relevant standards.
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:
No, an MRMC comparative effectiveness study was not done. This type of study is entirely irrelevant for a medical device like patient examination gloves, which are consumables and do not involve AI assistance, human readers, or image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This is also not applicable to patient examination gloves.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for performance evaluation is defined by established consensus standards and regulatory requirements.
- For Dimension, Physical Properties, and Powder Amount, the ground truth is defined by the specific parameters and tolerance limits outlined in ASTM standard D 5250-06.
- For Freedom from pinholes, the ground truth is defined by the visual inspection criteria and Acceptable Quality Limits (AQL) specified in 21 CFR 800.20.
- For Biocompatibility, the ground truth is established by the responses observed in animal models (rabbits for skin irritation, guinea pigs for dermal sensitization) according to the methodologies referenced (e.g., 15010993-10 or equivalent, although the specific standard is not fully detailed in the biocompatibility section, it's mentioned in (b)(1)). "Passing" these tests signifies that the material does not induce a significant adverse biological reaction as defined by the test protocols.
8. The Sample Size for the Training Set:
Not applicable/Not provided. This device is a physical product (gloves) and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable/Not provided. As there is no training set, there is no ground truth to establish for it.
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510 (K) Summary
AUG 22 2007
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
Premarket Notification |510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Langfang Huilong Plastic Product Co., Ltd. |
|---|---|
| Submitter's address : | Liu Ge Zhuang Developing Zone , DachengCounty ,Langfang City, Hebei Province |
| Phone number : | 86 311 84316178 |
| Fax number : | 86 311 84316178 |
| Name of contact person: | Mr. Zhenfeng GUAN |
| Date the summary was prepared: | June.16,2007 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powdered Vinyl Patient Examination Gloves,Clear (Non-colored) |
|---|---|
| Proprietary/Trade name: | Powdered Vinyl Patient Examination GlovesOther clients private labeling |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(a)(4)] A description of the device
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Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered vinyl patient examination glove, Clear(non-colored) 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powdered vinyl patient examination gloves, Clear (non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | $<10mg/dm²$ |
| Biocompatability | Primary Skin Irritation inrabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea pig | Passes | |
| Not a Dermal sensitization |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powdered vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and 15010993-10.
((b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
[(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powdered Vinyl Patient Examination Gloves, Clear(non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims .
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AUG 2 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Langfang Huilong Plastic Product Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company, Limited Room1606. Bulding.1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District, Beijing, China 100083
Re: K071686
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 14, 2007 Received: August 14, 2007
Dear Mr. Xiaoan:
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 -Mr. Xiaoan
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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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INDICATIONS FOR USE
Applicant: Langfang Huilong Plastic Product Co., Ltd.
510(k) Number (if known): *
Device Name: Powdered Vinyl Patient Examination Gloves, Clear(Non-colored)
Indications For Use:
Powdered vinyl 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devicer
Infection of Anesthestology, Gene
510(k) Number: K021684
§ 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.