(47 days)
A Powder Free Latex Surgical Glove is a disposable device intended in surgical settings for medical purpose that is worn on the hand to provide a barrier against potentially infectious materials and other contaminants.
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by the are and A surgeon's grove 15 a device intraction wound from contamination. (21CFR 878.4460)
Class I Surgeon's Glove (Powder Free) 79KGO that meets all the requirement of ASTM D3577.
Here's a breakdown of the acceptance criteria and study information for the BEIJING REAGENT LATEX PRODUCTS CO., LTD. "SNOW LOTUS" Powder Free Surgeon's Glove, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3577-00 Requirement for Latex Surgical Gloves Powder Free) | Reported Device Performance (Value) | Meets Criteria |
|---|---|---|---|
| Length | |||
| Size 6.5 | Min. 265mm | Min. 265mm | Yes |
| Size 7 | Min. 265mm | Min. 270mm | Yes |
| Size 7.5 | Min. 265mm | Min. 270mm | Yes |
| Size 8 | Min. 265mm | Min. 270mm | Yes |
| Size 8.5 | Min. 265mm | Min. 280mm | Yes |
| Size 9 | Min. 265mm | Min. 280mm | Yes |
| Width | |||
| Size 6.5 | 83 ± 6 mm | 77-88 mm | Yes |
| Size 7 | 89 ± 6 mm | 84-94 mm | Yes |
| Size 7.5 | 95 ± 6 mm | 90-100 mm | Yes |
| Size 8 | 102 ± 6 mm | 96-108 mm | Yes |
| Size 8.5 | 108 ± 6 mm | 102-114 mm | Yes |
| Size 9 | 114 ± 6 mm | 108-120 mm | Yes |
| Thickness | |||
| Cuff | Min. 0.10 mm | 0.14mm | Yes |
| Palm | Min. 0.10 mm | 0.18mm | Yes |
| Finger | Min. 0.10 mm | 0.22mm | Yes |
| Physical Properties (Before Aging) | |||
| Tensile Strength | 24 MPa | 28 MPa | Yes |
| Elongation at break % | 750% | 830% | Yes |
| Modulus at 500% elongation | 5.5 MPa (max) | 3 MPa | Yes |
| Physical Properties (After Aging) | |||
| Tensile Strength | 18 MPa | 21 MPa | Yes |
| Elongation at break % | 560% | 800% | Yes |
| Modulus at 500% elongation | (Not specified by ASTM) | 3 MPa | N/A |
| Powder Content | 2 mg/glove max | 0.38 mg/glove | Yes |
| Protein Content | (Not explicitly stated in ASTM D3577 table, but mentioned in performance) | 31.4 ± 0.05 µg/g | N/A |
| Biocompatibility | Biologically Compatible (FDA Requirement) | Biologically Compatible | Yes |
Study Details
-
Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the test set used for each parameter. It refers to "Inspection Level" and "AQL" (Acceptable Quality Limit) as per ASTM D3577 standards, implying that a statistically relevant sample size was drawn and tested according to these quality standards.
- Data Provenance: The tests were conducted by BEIJING REAGENT LATEX PRODUCTS CO., LTD., in P.R. CHINA. The data is retrospective, presented as a summary of compliance with recognized standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For physical and chemical tests of medical devices like gloves, "ground truth" is typically established through adherence to specified test methods and equipment calibration as defined by standards like ASTM D3577, rather than human expert consensus on interpretations.
-
Adjudication method for the test set:
- This information is not applicable in the context of physical and chemical testing of medical devices. Adjudication methods like 2+1 or 3+1 are relevant for subjective assessments, typically in image-based diagnostic studies. For these gloves, adherence to quantitative measurements against established standards is the method of assessment.
-
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 study was not done. This type of study is specifically for evaluating AI in diagnostic contexts, usually involving human readers interpreting medical images. This document describes a physical medical device (surgical gloves), not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes a physical medical device. There is no AI algorithm being evaluated for standalone performance.
-
The type of ground truth used:
- The ground truth used is defined by internationally recognized consensus standards and requirements, specifically ASTM D3577-00 for most parameters, and FDA requirements for Biocompatibility and Pinholes. This represents a set of objectively measurable physical and chemical properties.
-
The sample size for the training set:
- Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set."
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, this question does not apply.
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BEIJING REAGENT LATEX PRODUCTS CO., LTD.
ADD: NO.30 SOUTH SANLITUN ROAD, DONGDAQIAO, CHAOWAL, BEUING, P.R.CHINA. POST CODE: 100020 FAX: 86-10-81501067 TEL: 86-10-81502573
KOI2104
AUG 2 1 2001
510K SUMMARY as required by: 807.92 (c)
1.0APPLICANT
BEIJING REAGENT LATEX PRODUCTS CO., LTD. Name: NO. 30 SOUTH SANLITUN ROAD, DONGDAQIAO, CHAOWAI Add .: BEIJING, 100020 P.R.CHINA Tel NO. 86-10-81502573 Fax NO. 86-10-81501067
Contact person: MRS. WANG YANNAN GENERAL MANAGER
- 2.0 Device trade name: SNOW LOTUS Common Name: Surgeon's Glove Classification Name: Powder Free Surgeon's Glove
3.0 Legally marketed device to which the company claiming equivalence:
Class I Surgeon's Glove (Powder Free) 79KGO that meets all the requirement of ASTM D3577.
4.0 Description of the device:
Class I Surgeon's Glove (Powder Free) 79KGO that meets all the requirement of ASTM D3577.
5.0 Intended use of the Device:
A Powder Free Latex Surgical Glove is a disposable device intended in surgical settings for medical purpose that is worn on the hand to provide a barrier against potentially infectious materials and other contaminants.
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BEIJING REAGENT LATEX PRODUCTS CO., LTD. ADD: NO.30 SOUTH SANLITUN ROAD, DONGDAQIAO, CHAOWAI, BEIJING, P.R.CHINA. FAX: 86-10-81501067 POST CODE: 100020 TEL: 86-10-81502573
6.0 Technological characteristics of the device compared to predicate device.
| Measured Parameters of Latex Surgical Gloves Powder Freemanufactured by Beijing Reagent Products Co., Ltd. | ASTM D3577-00Requirement for LatexSurgical GlovesPowder Free | ||
|---|---|---|---|
| Characteristics | Size | Value | |
| Length | 6.5 | Min.265 mm | Min. 265mm |
| 7 | Min.270 mm | Min. 265mm | |
| 7.5 | Min.270 mm | Min. 265mm | |
| 8 | Min.270 mm | Min. 265mm | |
| 8.5 | Min.280 mm | Min. 265mm | |
| 9 | Min.280 mm | Min. 265mm | |
| Width | 6.5 | 77-88 mm | 83±6 mm |
| 7 | 84-94 mm | 89±6 mm | |
| 7.5 | 90-100 mm | 95±6 mm | |
| 8 | 96-108 mm | 102±6 mm | |
| 8.5 | 102-114 mm | 108±6 mm | |
| 9 | 108-120 mm | 114±6 mm | |
| Thickness | Cuff | 0.14mm | Min.0.10 mm |
| Palm | 0.18mm | Min.0.10 mm | |
| Finger | 0.22mm | Min.0.10 mm |
7.0 PHYSICAL PROPERTIES
| BEFORE AGING | AFTER AGING | |||
|---|---|---|---|---|
| Characteristics | Value | ASTM D3577 | Value | ASTM D3577 |
| Tensile Strength | 28MPa | 24MPa | 21MPa | 18MPa |
| Elongation at break % | 830% | 750% | 800% | 560% |
| Modulus at 500%elongation | 3MPa | 5.5Mpa(max) |
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BEIJING REAGENT LATEX PRODUCTS CO., LTD.
ADD: NO.30 SOUTH SANLITUN ROAD, DONGDAQIAO, CHAOWAL, BEIJING, P.R.CHINA. FAX: 86-10-81501067 TEL: 86-10-81502573
POST CODE: 100020
8.0 PERFORMANCE REQUIREMENT
| Characteristics | Relateddefects | InspectionLevel | Level as perASTM | AQL | AQL as perASTM D3577 |
|---|---|---|---|---|---|
| Sterility | Fails sterility | As per ISO | As per USP | N/A | N/A |
| Freedom fromHoles | Holes | G-I | G-I | 1.5 | 1.5 |
| Dimension | WidthLengthThickness | S-2 | S-2 | 4 | 4 |
| PhysicalProperty | TensilestrengthElongationAt breakbefore andafter aging | S-2 | S-2 | 4 | 4 |
POWDER CONTENT
| VALUE | ASTM REQUIREMENT |
|---|---|
| 0.38mg/glove | 2mg/glove max |
PROTEIN CONTENT
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BIOCOMPATIBILITY:
| VALUE | FDA REQUIREMENT |
|---|---|
| Biologically Compatible | Biologically Compatible |
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Image /page/3/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically "K012104". The characters are handwritten and appear to be on a white background. The numbers are clearly written and easy to read.
BEIJING REAGENT LATEX PRODUCTS CO., LTD. ADD: NO.30 SOUTH SANLITUN ROAD, DONGDAQIAO, CHAOWAI, BEIJING, P.R.CHINA. POST CODE: 100020 TEL: 86-10-81502573 FAX: 86-10-81501067
9.0 Performance Data:
The performance test data of the powder free surgical gloves manufactured by Beijing Reagent Latex Products Co., Ltd. is given below:
| Measured Parameters of Latex Surgical Gloves Powder Free | ||
|---|---|---|
| manufactured by Beijing Reagent Latex Products Co., Ltd. | ||
| Characteristics | Size | value |
| Length | 6.5 | Min.265 mm |
| 7 | Min.270 mm | |
| 7.5 | Min.270 mm | |
| 8 | Min.270 mm | |
| 8.5 | Min.280 mm | |
| 9 | Min.280 mm | |
| Width | 6.5 | 77-88 mm |
| 7 | 84-94 mm | |
| 7.5 | 90-100 mm | |
| 8 | 96-108 mm | |
| 8.5 | 102-114 mm | |
| 9 | 108-120 mm | |
| Thickness | Cuff | 0.14mm |
| Palm | 0.18mm | |
| Finger | 0.22mm |
PHYSICAL PROPERTIES
| Characteristic | Before Aging | After Aging |
|---|---|---|
| Tensile Strength | 28MPa | 21MPa |
| Elongation at break % | 830% | 800% |
| Modulus at 500% elongation | 3MPa | 3MPa |
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BEIJING REAGENT LATEX PRODUCTS CO., LTD.
Image /page/4/Picture/1 description: The image shows a sequence of handwritten numbers. The numbers appear to be "1012104". The numbers are written in black ink on a white background. The handwriting is somewhat stylized, with some numbers slightly overlapping.
ADD: NO.30 SOUTH SANLITUN ROAD, DONGDAQIAO, CHAOWAI, BEIJING, P.R.CHINA. POST CODE: 100020 TEL: 86-10-81502573 FAX: 86-10-81501067
PERFORMANCE REQUIREMENT
| Characteristics | Related defects | LEVEL | AQL |
|---|---|---|---|
| Sterility | Fails sterility | N/A | N/A |
| Dimension | WidthLengthThickness | S-2 | 4.0 |
| Freedomfrom Holes | Holes | S-4 | 1.5 |
| PhysicalProperty | TensilestrengthElongationAt breakbefore andafter aging | S-2 | 4.0 |
POWDER CONTENT: PROTEIN CONTENT: 31.4±0.05 Hg/g BIOCOMPATIBILITY: Biologically Compatible
- Clinical Data: N/A
11. CONCLUSION OF PERFORMANCE TEST DATA:
The Powder Free Surgical Glove manufactured by BEIJING REAGENT LATEX PRODUCTS CO., LTD. Meet or exceed the ASTM D 3577 Meet FDA Pin holes Requirement Meet labeling claim as shown by the Requirment
12. ANY OTHER INFORMATION
Any other information required by FDA regarding product safety and effectiveness will be provided on request.
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and sides of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2001
Mr. Wang Yannan General Manager Beijing Reagent Latex Products No. 30 South Sanlitun Road, Dongdaqiao Chaowai, Beijing, P.R. CHINA
K012104 Re : "Snow Lotus" Powder-Free Latex Trade/Device Name: Surgeon's Gloves 878.4460 Regulation Number: Regulatory Class: I Product Code: KGO Dated: November 30, 2001 Received: July 5, 2001
Dear Mr. Yannan:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beccion 310mm, and we have determined the market the device fererenced above the indications for device is substancially equivalently marketed predicate use stated in the encreate, commerce prior to May 28, 1976, devices marketed in incerbead as Device Amendments, or to the enactment date of the neasified in accordance with the devices that have been recrabbilding, and Cosmetic Act (Act).
provisions of the Federal Food, and inchingt to the general provisions of the reactar toon andy, subject to the general controls provisions of the Act. The general controls controls provisions of choude requirements for annual provisions of the Act therauc requeed manufacturing practice, registration, firsting or as resinst misbranding and adulteration.
If your device is classified (see above) into either class II II your device is crabblied (boo wearket Approval), it may (Special Controls) or Stimbling Controls. Existing major be subject to such addrerends ice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulations, freic ar, farob assumes compliance with Subscancially equivalenceuring Practice requirements, as set the Current Good Manaracter Regulation (QS) for Medical Forch In the Quarty of CFR Part 820) and that, Devices. Ocheral regarations, the Food and Drug Chrough periodic QB Inbecount) such assumptions. Failure to
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Page 2 - Yannan
comply with the GMP regulation may result in regulatory Ith the GMP regulation may publish further announcements action. action. In addition, FDA may purchasis manufactor of the mote:
concerning your device in the tendersion whicssion does concerning your device in the readlication submission does this response to your premaince neer have under sections 531 not affect any obligation you might under the Electronic through 542 of the Act 101 devices and 1 and 1 mm . . . Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as This lecter will afrow your smarket notification.
described in your 510(k) premarket notification. The FDA described in your 510\x) prematice notribution to a legally
finding of substantial equivalence of your leggification for your finding of substancial equivalines of plassification for your marketed predicate device resures in a olaboration.
device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice rol additionally 809.10 for in regulation (21 cm Fare over are over act the Office of
vitro diagnostic devices), please contact the for quogti Compliance at (301) 594-4622. Additionally, for questions on Compliance at (301) 354 ising of your device, please contact the promotion and advertising or your actise.
the Office of Compliance at (301) 594-4639. Also, please note ene regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premarket notification (zick over the Act may be Information on your respon of Small Manufacturers obtained from the Division or among comment its toll-free number International and Comsumer Abbrando at its internet address (800) 650 2041 01 - (202) /dsma/dsmamain.html".
Sincerely yours,
Patricia Cuenite/for
Timothy A. Ulatowski Director Director and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
Applicant: Beijing Reagent Latex Products
510(k) Number (if known): _KOLZI_O 4
Device Name: Powder Free Latex Surgeon's Gloves
Indications For Use:
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by
the are and A surgeon's grove 15 a device intraction wound from contamination. (21CFR 878.4460)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qiu S. Lim
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division oral Hospital Device 510(k) Number --
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).