A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

Device Description

Shanghai China Star Corp Powder free blue Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device powdered with absorbable dusting powder that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Shanghai China Star Corp Powder Free Blue Nitrile Patient Examination Glove, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test / Characteristic	Acceptance Criteria (from predicate/standard)	Reported Device Performance (New Device)
Physical Specifications
Width (size medium)	92mm (Predicate K040841)	92mm
Overall length	240mm (Predicate K040841)	240mm
Palm thickness	0.17mm (Predicate K040841)	0.17mm
Finger thickness	0.18mm (Predicate K040841)	0.18mm
Tensile strength pre-aging min	21mpa (Predicate K040841)	21mpa
Tensile strength after-aging min	16mpa (Predicate K040841)	16mpa
Ultimate elongation pre-aging min	500 (Predicate K040841)	500
Ultimate elongation after-aging min	500 (Predicate K040841)	500
Performance Testing
Dermal Sensitization Test	Passes (Predicate K040841, K022765)	Passes
Primary Skin irritation	Passes (Predicate K040841, K022765)	Passes
Permeation testing	Not explicitly stated as "Passes" criteria, but ASTM D 6978-05 standard implies expected performance	Passes
Iodine Test	Not explicitly stated as "Passes" criteria	Passes
Tensile strength (ASTM D6319-00a)	Meets requirements of ASTM D6319-00a	Gloves meet the requirements of ASTM D6319-00a.
Barrier strength (ASTM D6319-00a)	Meets requirements of ASTM D6319-00a	Gloves meet the requirements of ASTM D6319-00a.
Residual powder test	Passes (Predicate K040841, K022765)	Passes
Biocompatibility standards	Yes (Predicate K040841, K022765)	Yes
Duration of biocompatibility	Limited (Predicate K040841, K022765)	Limited
Pinholes	AQL 2.5 (ASTM D 6319-00a)	AQL 2.5
General Inspection Level	S-2 (ASTM D 6319-00a)	S-2
General AQL for Inspection	AQL 4.0 (ASTM D 6319-00a)	AQL 4.0

Study Details:

The provided document describes a 510(k) premarket notification which aims to demonstrate that a new device is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway, not a traditional clinical study designed to "prove" device performance in the same way a randomized controlled trial would. Instead, it relies on demonstrating that the new device meets established standards and performs similarly to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document repeatedly references "Inspection level S-2, AQL 4.0" and "pinholes at AQL 2.5" as per ASTM D 6319-00a. These are sampling plans for quality control, not a fixed sample size for a "test set" in the context of clinical studies. ASTM D 6319-00a specifies statistical sampling procedures for examination gloves. The exact sample size would depend on the lot size being tested according to the standard.
Data Provenance: The document does not explicitly state the country of origin for the testing data, although the applicant and manufacturer are based in Shanghai, China. The testing appears to be retrospective in the sense that it's performed on manufactured gloves to demonstrate compliance with standards, rather than a prospective study observing usage in a real-world setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable (N/A) in this context. The "ground truth" for this device's performance is established by conformance to recognized international standards (ASTM D 6319-00a, ASTM D 6978-05) and comparison to existing predicate devices. There isn't a need for expert consensus on interpreting complex medical images or clinical outcomes here. The tests are objective measurements against defined criteria.

4. Adjudication Method for the Test Set

N/A. As explained above, this is not a study requiring adjudication of expert opinions or clinical outcomes. The tests are objective and deterministic.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is typically used for diagnostic imaging devices to assess how human readers' performance with and without AI assistance changes. This document describes examination gloves, which do not involve diagnostic interpretation by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A. This device is a physical product (gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" used for this device is primarily established industry standards (ASTM D 6319-00a and ASTM D 6978-05) and the performance specifications of legally marketed predicate devices (K040841, K022765). These standards define the acceptable physical properties and performance characteristics (e.g., tensile strength, barrier integrity, biocompatibility).

8. The Sample Size for the Training Set

N/A. This is not a machine learning or AI device that requires a "training set." The device is a manufactured product tested against defined specifications.

9. How the Ground Truth for the Training Set was Established

N/A. No training set is involved.

Summary

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SHANGHAI CHINASTAR COR

No#283 Che Xin Rd, Che Dun Zhen, Song Jaing County Shanghai, China C/O: 11F No.201, Nanking East Rd., Sec 3, Taipei, Taiwan, R.O.C Tel:886-2-2713-6677 Fax:886-2-2546-2480

510(k) Summary

K071072

Prepared: March 28, 2007

Applicant	Shanghai China Star CorpNo. 283, Che Xing Road, Che Dun Zhen,Song JiangCounty: Shanghai, China
Manufacturer	Shanghai China Star CorpNo. 283, Che Xing Road, Che Dun Zhen,Song JiangCounty: Shanghai, China
Submitter	Romil RambhiaOfficial Correspondent forShanghai China Star Corp
Address	mdi Consultants, Inc.55 Northern Blvd., Suite 200Great Neck, New York 11021Tel: 516-482-9001Fax: 516-482-0186romil@mdiconsultants.com
Trade/proprietary Name	Shanghai China Star CorpPowder free Blue Nitrile PatientExamination Glove tested withchemotherapy drugs.
Common Names	POWDER-FREE Patient ExaminationGlove
Classification name	Patient Examination Glove
Classification number	21 CFR 880.6250

Device Description:

Intended Use:

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or to prevent finger examiner. These gloves are not intended to be used as a chemical barrier

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Substantial Equivalence Discussion:

Characteristicand parameters	Shanghai China StarCorp(New Device)	MEDLINEINDUSTRIES, INC(K) 040841	ALLEGIANCEHEALTHCARECORP.(K) 022765
Product Code	LZA	LZA	LZA
Intended Use	A powder free patientexamination glove(Tested for Use withChemotherapy Drugs)is a disposable deviceintended for medicalpurposes that is wornon the examiners handor finger to preventcontamination betweenpatient and examiner.These gloves are notintended to be used as achemical barrier	Medline Powder-FreeBlue NitrileExamination Gloves(Tested for Use withChemotherapyDrugs) is adisposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger topreventcontaminationbetween patient andexaminer.	A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. In addition,these gloves are wornto protect the weareragainst exposure tochemotherapy drugs.The gloves with testedfor use withchemotherapy drugslabeling claims.
Width (sizemedium)	92mm	92mm	N/A
Overall length	240mm	240mm	N/A
Palm thickness	0.17mm	0.17mm	N/A
Finger thickness	0.18mm	0.18mm	N/A
Tensile strengthpre aging min	21mpa	21mpa	N/A
Tensile strengthafter aging min	16mpa	16mpa	N/A
Ultimateelongation preaging min	500	500	N/A
Ultimateelongation afteraging min	500	500	N/A
MeetsBiocompatibilitystandards	Yes	Yes	Yes
Duration of bio-compatibility	Limited	Limited	Limited
Skin irritation test	Passes	Passes	Passes
Dermalsensitization	Passes	Passes	Passes
Residual powdertest	Passes	Passes	Passes

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is substantially equivalent to the predicate devices.

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N/A is we don't know the specifications.

Summary of Testing:

Test	Results
1. Dermal Sensitization Test	Passes
2. Primary Skin irritation	Passes
3. Permeation testing per ASTM D 6978-05	Passes
4. Iodine Test	Passes
5. Tensile strength	Gloves meets the requirements ofASTM D63 19-00a.
6. Barrier strength	Gloves meets the requirements ofASTM D63 19-00a.

The standards used by Shanghai Chinstar Corp to determine substantial equivalence are based on ASTM D 631900a-2005. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5

There are no special labeling claims and we do not claim our gloves to be hypoallergenic.

Conclusion:

Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs performance was equivalent to any other conventional method evaluated. Our evaluation concluded that our device raises no new issues of Safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem depicting a stylized eagle with three overlapping profiles, symbolizing health, services, and people. The eagle is a common symbol of the United States, representing freedom and strength.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai China Star Corporation C/O Mr. Romil Rambhia Official Correspondent mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11001

AUG 3 0 2007

Re: K071072

Trade/Device Name: Shanghai China Star Corp Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 21, 2007 Received: August 22, 2007

Dear Mr. Rambhia:

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. Rambhia

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 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 (301) 594-4618. 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/dsma/dsmamain.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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Indications for Use

510(k) Number (if known): Not Assigned as of now

1/07/072

Applicant: Shanghai China Star Corp

Device Name: Shanghai China Star Corp Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs.

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Shula A Murphy, 6

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K021072

Regulation Number and Section

§ 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.