(131 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)
The provided text describes the specifications and quality control scheme for vinyl patient examination gloves, rather than a medical device with an algorithm or AI component requiring a study to prove acceptance criteria in the typical sense of AI/ML devices. Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.
However, I can extract the acceptance criteria and the methods used to show the device meets those criteria based on the provided information, which primarily references ASTM and ISO standards for physical characteristics and manufacturing quality.
Here's a summary tailored to the provided document:
Acceptance Criteria and Device Performance for Vinyl Patient Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines acceptance criteria based on two main sections:
- "SPECIFICATION OF VINYL GLOVES (Ambidextrous)" (Page 2) which lists specific physical dimensions and performance requirements. This section appears to be the target specification for the gloves.
- "PERFORMANCE REQUIREMENTS FOR QUALITY CHARACTERISTICS" AND "QUALITY CHARACTERISTICS" (Pages 5-6) which detail the quality control parameters and their associated Assurance Actions and AQLs (Acceptable Quality Levels). This section describes how the product is monitored and accepted during manufacturing.
Table 1: Acceptance Criteria and Reported Device Performance (Summary from Specifications and Quality Control)
| Characteristic | Acceptance Criteria (Specification) & Assurance Action | Reported Device Performance (Implied by meeting standards) |
|---|---|---|
| Physical Dimensions | ||
| Circumference of Palm | Small: 178mm (6-3/4")Medium: 210mm (7-3/4")Large: 218mm (8-1/2")Ex-Large: 230mm (9") | Meets JIS-S-2045.509 |
| Total Length | 240-245mm (+/- 5 mm) | Meets JIS-S-2045.5.9 |
| Length of Fingers | Varies by finger & size (e.g., Small Thumb: 55mm, Middle Finger: 74mm) | Meets JIS-S-2045.5.9 |
| Circumference of Fingers | Varies by finger & size (e.g., Small Thumb: 63mm, Middle Finger: 59mm) | Meets JIS-S-2045.5.9 |
| Overall Length (QC) | 240 +/- 10 mm (Test method A1, Inspection level S-2, AQL 2.5) | Meets specification (Implied) |
| Width (QC) | Small: 83 +/- 5 mmMedium: 94 +/- 5 mmLarge: 105 +/- 5 mmEx-Large: 114 +/- 5 mm | Meets specification (Implied) |
| Thickness | ||
| Finger Tip | 0.08 mm +/- 0.02 mm | (Not explicitly shown whether met from spec table) |
| Cuff | 0.09 mm +/- 0.02 mm | (Not explicitly shown whether met from spec table) |
| Palm | 0.15 mm +/- 0.02 mm | (Not explicitly shown whether met from spec table) |
| Thickness (QC, double wall) | Finger: 0.48 mm Max.Cuff: 0.20 mm Min. (Dimensional control, Inspection level S-2, AQL 2.5) | Meets specification (Implied) |
| Mechanical Properties | ||
| Tensile Strength (Before Aging) | Min. 10.0 Mpa | Meets JIS-S-2045.5.2 |
| Elongation (Before Aging) | Min. 350% | Meets JIS-S-2045.5.2 |
| Tensile Strength (After Aging) | Min. 10 Mpa (Test method A4, Inspection level S-2, AQL 2.5) | Meets specification (Implied) |
| Elongation (After Aging) | Min. 350% (Test method A4, Inspection level S-2, AQL 2.5) | Meets specification (Implied) |
| Other Properties | ||
| Weight | 7.0-9.5 g/pc (+/- 0.2g) | (Implied to meet specification) |
| Pinhole Rate | Under 2.5% Pinhole Rate (FDA Glove 1000ml Water Leak Test) | Meets specification (Implied) |
| Inside pH (QC) | 7 +/- 1 (Test method A2, Inspection level S-2, AQL 2.5) | Meets specification (Implied) |
| Powder level (QC) | Inside: max. 2.5 +/- 1.0 by weightOutside: max. 1.0% by weight (Test method A3, Inspection level S-2, AQL 2.5) | Meets specification (Implied) |
| Pinhole & Visual Defects (QC) | AQL 1.0 for Category 1 defects (Holes, cuts, tears)AQL 2.5 for Category 2 defects (Pleats, Lumps, Dirty/foreign spot, Embedded particles, Thin spots, Discoloration, Torn bead) | Meets specification (Implied) |
| Final Glove Release | AQL 1.5 for leaksAQL 4.0 for leaks and visual defects aggregated (Inspection level 1, normal inspection, multiple sampling) | Meets US FDA Test Method for Leakage Defects |
The conclusion states: "The vinyl Patient Examination gloves (Pre-powdered) manufactured by Evergreen Medical products (Jingxing) Co., Ltd. meet ASTM D5250-99 Standard and meet pinhole requirements and labeling claims." This is the direct statement of performance against the acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document refers to sampling procedures in accordance with ISO 2859 ("Sampling procedures and Tables for Inspection by Attributes"). It also mentions "median of not less than three measurements" for thickness (A.1), "median of at least 10 results" for residual powder (A.3), and "median of not less than 5 test results" for physical requirements (A.4). However, specific numerical sample sizes for the overall test set (e.g., number of gloves tested for full compliance) are not explicitly stated. The AQL (Acceptable Quality Level) values (e.g., 2.5, 1.0, 1.5, 4.0) and Inspection Levels (e.g., S-2, II, 1) refer to the statistical sampling plans within ISO 2859 and US FDA Test Methods, which would dictate the sample sizes based on lot size, but these specific numbers are not provided.
- Data Provenance: Not applicable in the context of an "AI device." The testing would be performed on manufactured batches of physical gloves at the manufacturing site (Evergreen Medical Products (Jingxing) Co., Ltd.) in China, as part of their quality control process. The biocompatibility testing was "Issued by Consumer Products Testing Co."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical product (gloves) and not an AI/ML device relying on expert-labeled data. Ground truth here refers to adherence to objective physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the reasons stated above. Testing involves measuring characteristics against predefined physical/chemical limits. Visual inspection for defects ("Visual, Sensual" in Section 22.0) would follow established quality control protocols, but not multi-expert adjudication in the AI sense.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- The "ground truth" for the device's performance is adherence to established international and national standards for medical gloves:
- ASTM Specification D 5250-99 (Standard Specification for Vinyl Examination Gloves for Medical Application) for general glove properties.
- JIS-S-2045.509/5.9/5.2 for specific dimensions and mechanical tests.
- ISO 2859 for sampling procedures.
- US FDA Test Method for Leakage Defects as published in the Federal Registration of Nov. 31, 1989 (21 CFR Part 800.20) for pinholes.
- ASTM D 3578 (Standard Specification for Rubber Examination Gloves) for physical requirements (aging).
- BS 4005 (Single Use Sterile Surgical Rubber Gloves, Appendix C) for air inflation and cuff test (partial adherence).
- Biocompatibility testing results (Primary Dermal Irritation in Rabbits, Guinea Pig Sensitization) for safety.
- Chemical composition (Polyvinyl Chloride, Plasticizers, etc.) against specified percentages.
- Manufacturing Practice: Compliance with current Good Manufacturing Practice (GMP) requirements.
8. The sample size for the training set:
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
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Image /page/0/Picture/0 description: The image contains Chinese characters followed by the English text "EVERGREEN MEDICAL PRODUCTS CO., LTD." The Chinese characters are above the English text. The text is in a sans-serif font and is black on a white background. The image appears to be a company logo or heading.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, lingxing County, Shijiazhuang City, Hebei 050306, China Tel: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
APR 1 2 2000
Date: Feb. 22, 2000 Total pages: 3
1.0 APPLICANT:
Evergreen Medical Products (Jingxing) Co., Ltd. No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306 China Tel: +(86 311) 236 1035, 236 0652 Fax: +(86 311) 236 0670 E-mail: chenjul@ms13.hinet.net
2.0 Contact Person:
Doreen Feng Tel: +(86 311) 236 1035, 236 0652 Fax: +(86 311) 236 0670
3.0 DEVICE CLASS: JY
PRODUCT CODE: Vinyl (Pre-Powdered) - 80 LYZ
- 4.0SPECIFICATION: Glove, Patient Examination, Vinyl (Pre-powdered) Meet all the current specifications listed under ASTM Specification D 5250-99
5.0 DEVICE DESCRIPTION:
Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)
6.0 INDICATION FOR USE (INTENDED USE):
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.
7.0INNER SURFACE: Pre-powdered
8.0 BIOCOMPATIBILITY TESTING:
- Primary Dermal Irritation in Rabbits -
- -Guinea Pig Sensitization (Buehler)
Issued by Consumer Products Testing Co.
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Image /page/1/Picture/0 description: The image shows the name of a company in both Chinese and English. The Chinese characters are at the top, and the English name, "EVERGREEN MEDICAL PRODUCTS CO., LTD." is below. The English name is in a bold, sans-serif font and has a textured fill. There is a line underneath the English name.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 el: + (86 311) 236 1018, 236 1035
9.0 QUALITY CHARACTERISTICS
510 (K) Summary: Page 2
SPECIFICATION OF VINYL GLOVES (Ambidextrous)
| SizeSpec. | Small | Medium | Large | Ex-Large | Test code |
|---|---|---|---|---|---|
| Circumferenceof Palm (mm)(Inch) | 1786-3/4 | 2107-3/4 | 2188-1/2 | 2309 | JIS-S-2045.509 |
| Total Length(+/- 5 mm) | 240 | 245 | 245 | 245 | JIS-S-2045.5.9 |
| Length ofFingers (mm)ThumbsIndex FingerMiddle FingerRing FingerLittle Finger | 5566746954 | 5770817450 | 6175837960 | 6378928262 | JIS-S-2045.5.9 |
| CircumferenceFingers (mm)ThumbIndex FingerMiddle FingerRing FingerLittle Finger | 6356595650 | 7164666357 | 7870726962 | 8374767366 | JIS-S-2045.5.9 |
| Tensile Strength(Mpa) | Min.10.0 | Min.10.0 | Min.10.0 | Min.10.0 | JIS-S-2045.5.2 |
| Elongation (Min.) | 350% | 350% | 350% | 350% | JIS-S-2045.5.2 |
| Weight (g/pc) | 7.0 | 8.0 | 9.0 | 9.5 | +/- 0.2g |
| Thickness | Finger Tip0.08 mm +/- 0.02 mmCuff0.09 mm +/- 0.02 mmPalm0.15 mm +/- 0.02 mm | ||||
| QualityAssurance | Under 2.5% Pinhole Rate | FDA Glove 1000mlWater Leak Test |
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Image /page/2/Picture/0 description: The image shows the name of a company in both Chinese and English. The Chinese characters at the top read "Chang Rong Medical Products Co., Ltd." Below this, the English translation "EVERGREEN MEDICAL PRODUCTS CO., LTD." is displayed in a bold, outlined font. The English text is set against a textured background, adding visual interest to the company's name.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, "ingxing County, Shijiazhuang City, Hebei 050306, China : +(86 311) 236 1018, 236 1035 Fax: +(86 311) 236 0670
510 (K) Summary: Page 3
10.0 CONCLUSION:
The vinyl Patient Examination gloves (Pre-powdered) manufactured by Evergreen Medical products (Jingxing) Co., Ltd. meet ASTM D5250-99 Standard and meet pinhole requirements and labeling claims.
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Image /page/3/Picture/0 description: The image shows the text "EVERGREEN MEDICAL PRODUCTS CO., LTD." in a bold, sans-serif font. Above this text is the same company name in Chinese characters. The English text is underlined with a thin black line.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, lingxing County, Shijiazhuang City, Hebei 050306, China Tel: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
Total pages: 6
GENERAL QUALITY CONTROL SCHEME
1.0 PRODUCT
Vinyl Patient Examination Gloves Pre-Powdered, Non-Sterile
2.0 INTENDED USE
A medical glove is to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluid, waste, or environment".
3.0 DONNING POWDER
U. S. P. Absorbable Dusting Powder, Neutral pH
- U. S. FDA approved under ANDA (Abbreviated new Drug Application 809535)
U. S. FDA Medical Device Establishment manufacturing Registration Number for manufacturing site.
Name of supplier of USP powder: Shieh-Tai Chemical & Starch Co., Ltd. Brand name of USP powder: Modified Starch Extra 226.
4.0 COMPONENTS
| Polyvinyl Chloride | 45.90% |
|---|---|
| Di-2-Ethylhexyl Phthalate | 45.90% |
| 2,2,4-Trimethyl-1, 3-Pentanediol | 4.50% |
| Calcium, Zinc Sterates | 2.30% |
| Epoxidized Soyabean Oil | 0.50% |
| Absorbable Powder for Lubrication | < 120 milligram/glove |
5.0 SHAPE
Straight fingers, thumb and fingers in one plane, fist either hand, rolled rim
6.0 SIZE
Small (S), Medium (M), Large (L), Extra-Large (XL)
7.0 COLOR
Natural color, no color additive
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Image /page/4/Picture/0 description: The image shows the text "EVERGREEN MEDICAL PRODUCTS CO., LTD." in a large, outlined font. Above this text is the same company name written in Chinese characters. The text is centered and takes up most of the image. The background is a grainy texture.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China el: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
8.0 MARKING
General Quality control scheme: Page 2
Gloves are marked to designated size
9.0 PACKING
As per packing specification
10.0 LABELING
10.1Control Number
Each packing unit (dispenser box) and outer cartons bears a control number Example: EVX1991230888
EV .................................... Abbreviation of factory name
XI99 ............................. Production month and year
123 ........................................ Internal running order number
0888 .............................. Case number
10.2Manufacturing dating
Each packing unit (dispenser box) or outer cartons bears the manufacturing dating.
10.3Caution words on the box
"Caution: Users should consider the circumstance of use in deciding whether to remove residual powder from gloves after donning. Powder can be removed by thoroughly wiping gloves with a sterile wet sponge, sterile wet towel, or other effective method."
11.0 PERFORMANCE REQUIREMENTS FOR QUALITY CHARACTERISTICS
For reference purpose in accordance with ISO 2859 Sampling procedures and Tables for Inspection by Attribute.
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No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 el: + (86 311) 236 1018, 236 1035
General Quality Control Scheme: Page 3
12.0 QUALITY CHARACTERISTICS
| Description | Specification | Assurance Action |
|---|---|---|
| DimensionsOverall Length | 240+/- 10 mm | Test method A1Dimensional controlInspection level S-2AQL 2.5 |
| Width | Small 83 +/- 5 mmMedium 94 +/- 5 mmLarge 105 +/- 5 mmEx-Large 114 +/- 5 mm | |
| Thickness(Double wall) | Finger 0.48 mm Max.Cuff 0.20 mm Min. | |
| Chemical PropertiesInside pH | 7 +/- 1 | Test method A2Inspection level S-2AQL 2.5 |
| Powder levelInsideOutside | max. 2.5 +/- 1.0 by weightmax. 1.0% by weight | Test method A3Inspection level S-2AQL 2.5 |
| Physical PropertiesBefore AgingTensile StrengthElongation at break | Min. 10 MpaMin. 350% | Test method A4Inspection level S-2AQL 2.5 |
| After Aging(70°C, 166 hoursTensile StrengthElongation at break | Test method A4Min. 10 MpaMin. 350% | Inspection level S-2AQL 2.5 |
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Image /page/6/Picture/0 description: The image contains Chinese characters at the top and the English text "EVERGREEN MEDICAL PRODUCTS CO., LTD." below. The Chinese characters appear to be a company name, likely the same as the English text. The text is bold and in a sans-serif font, with a slightly distressed or textured appearance. The overall image seems to be a company logo or letterhead.
No. 1. Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 el: + (86 311) 236 1018, 236 1035
General Quality Control Scheme: Page 4
13.0 INTERNAL ATTRIBUTIVE RELEASE INSPECTION
Examination
Sampling for examination accordance with ISO 2859 Sampling Procedures and Tables for Inspection by Attributes.
Unit for Examination: one (1) glove
If several defects are found on one glove, only the most serious defect (i. e. lowest category) is evaluated. The acceptance criteria are based on the number of defective observed in a sample.
14.0 PIN HOLE AND VISUAL DEFECTS
Assurance Action
Sampling Inspection by Air inflation and cuff sorting (method A5), inspection level II Performance requirements:
| Category of Defect | AQL |
|---|---|
| 1 | 1.0 |
| 2 | 2.5 |
15.0 FINAL GLOVE RELEASE
15.1 Assurance Action
U. S. FDA Test Method for Leakage Defects published in the Federal Registration of Nov. 31, 1989 (21 CFR Part 800.20)
15.2 Sampling Inspection
AQL 1.5 for leaks AQL 4.0 for leaks and visual defects aggregated. Inspection level 1, normal inspection, multiple sampling
16.0 PACKAGING, MARKING, GOOD DELIVERY INSPECTION
Assurance Action Set-up and patrol inspection at packaging Supervision of vehicle or vessel loading
17.0 GOOD MANUFACTURING PRACTICE
The gloves are manufactured in compliance with the current Good manufacturing Practice (GMP) requirements in the United States of America as appropriate for patient examination gloves.
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Image /page/7/Picture/0 description: The image contains the name of a company in both Chinese and English. The Chinese characters at the top read "Chang Rong Medical Products Co., Ltd." The English translation below reads "EVERGREEN MEDICAL PRODUCTS CO., LTD." The English text is in a bold, outlined font.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, ingxing County, Shijiazhuang City, Hebei 050306, China Tel: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
General Quality Control Scheme: Page 5
18.0 MICROBIOLOGICAL CLEANLINESS CONTROL
The bioburden of the finished gloves are monitored and recorded. Unusual contaminants are identified. It is attempted to determine their sources and eliminating or reducing their impact.
19.0 CAUTION
Non-sterile examination gloves are used in a variety of circumstances, including procedures where the surface of the glove contacts wounds, body cavities, or other possible routes of contamination. If conditions warrant, the user may wish to minimize the risk of infection. In this case, we recommend the decontamination of the gloves prior to use by disinfectants or other effective methods.
20.0 STORAGE
According to ISO 2230
Keep storage areas cool, dry and dust free, avoid ventilation. Protect gloves against ultraviolet light sources, as sunlight and oxidizing agents. Cooper ions discolor the gloves.
21.0 REFERENCED TEST METHODS
A. 1 Physical Dimensions
Adherence to ASTM D 5250, for length and width press ruler on the flat glove. Measure double film thickness of an intact glove, and report the median of not less than three measurements at different locations.
A. 2 Surface pH of Glove Inside
Warm 50 ml distilled water to 38 +/- 2℃. Fill the glove and twist to close the cuff end. Wash the glove inside and squeezing. Pour content into a beaker and measure pH.
A. 3 Residual powder
5 air dried gloves are weighted together and afterwards rinsed in water to remove Then the gloves are air dried to constant weight for approximately 12 hours. powder. The quantity of powder is determined by the decrease in weight. Limiting values apply to the median of at least 10 results.
A. 4 Physical Requirements
Adherence to ASTM D 3578. Use same glove to compare before and after aging. Report the median of not less than 5 test results for each requirements.
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Image /page/8/Picture/0 description: The image shows the logo of Evergreen Medical Products Co., LTD. The logo is in both Chinese and English. The Chinese characters are on top, and the English words are on the bottom. The English words are in a sans-serif font and are underlined.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China el: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
General Quality Control Scheme: page 6
A. 5 Air Inflation and Cuff Test
Partial adherence to BS 4005, Single Use Sterile Surgical Rubber Gloves, Appendix C. Inflate glove with air approximately to a diameter of 200 mm and fan in front of face. Listen for air leakage and feel it. Visually examine for defects. Stretch cuff next to edge and inspect visually. Validated against FDA water leak test.
22.0 LIST OF DEFECT
| Category | Defect | Test method |
|---|---|---|
| 1 | Holes, cuts, tears | Visual, Sensual |
| 2 | Pleats and Lumps in critical areaContents not as specified(size, former type)Dirty/foreign spot on surface more than2 per glove or > 0.5 mmEmbedded particles > 1 mm, more than 2 per gloveThin spotsDiscoloration, bloomingTorn, broken or open beadPleats, lumps in non-critical area | VisualVisualVisual |
- End of document -
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Image /page/9/Picture/2 description: The image shows a black and white logo of the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes. The words "DEPARTMENT OF HEALTH & H.S." are arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2000
Ms. Doreen Feng Evergreen Medical Products (Jingxing) Co., Ltd. No. 1, Evergreen Road The North of Beishimen Village Xiaozuo Town, Jingxing County Shijiazhuang City, Hebei 050306 CHINA
Re : K994099 Vinyl Patient Examination Gloves- Pre-Trade Name: powdered Requlatory Class: I Product Code: LYZ February 22, 2000 Dated: Received: April 3, 2000
Dear Ms. Feng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your
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Page 2 - Ms. Feng
premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo v A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Tel: + (86 311) 236 1018, 236 1035 Fax: + (86 311) 236 0670
INDICATION FOR USE STATEMENT
| Applicant: | Evergreen Medical Products (Jingxing) Co., Ltd. |
|---|---|
| 510(K) Number: | K994099 |
| Device Name: | Vinyl Patient Examination Gloves - Pre-powdered |
Indication for use:
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Concurrence of CDRH Office of Device Evaluation (ODE)
Claire S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 5100k) Number .
Prescription Use _ Per 21 CFR 801.109
Over-The-Counter OR
§ 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.