(122 days)
Not Found
No
The device is a disposable patient examination glove, a Class I medical device with no mention of AI/ML in its description or performance studies.
No.
The device, White Vinyl Exam Gloves Powder Free, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition. It is classified as a Class I general and plastic surgery device and serves as a barrier.
No
Explanation: The device is a patient examination glove, which is used for preventing contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical examination glove, which is a hardware device, not software. The description explicitly states it is a disposable device worn on the hands or fingers.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hands. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description clearly states it's a "disposable device intended for medical purposes that is worn upon the examiner's hands or fingers". It's classified as a Class I device under "General and Plastic Surgery Device panel".
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical properties (dimensions, water fill test), biocompatibility (skin irritation, sensitization), and powder content, which are relevant for a barrier device, not an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or linger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical tests performed for Determination of Substantial Equivalence:
The standards used for Shandong Dawei Medical Products Co., I.td. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQI. 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5. Inspection Level I, 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.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tensile Strength(Mpa): Before Aging: Proposed Device - 16.84, Predicate Device - 16.80. After Aging: Proposed Device - 14.96, Predicate Device - 15.
Ultimate Elongations: Before Aging: Proposed Device - 520%, Predicate Device - 510%. After Aging: Proposed Device - 481%, Predicate Device - 480%.
Overall Length on Medium Size: Proposed Device - over 232.23mm, Predicate Device - over 232mm.
Width of Palm on Medium Size: Proposed Device - 95mm, Predicate Device - 96mm.
Palm Thickness: Proposed Device - 0.095 mm, Predicate Device - 0.096 mm.
Figure Thickness: Proposed Device - 0.090 mm, Predicate Device - 0.091 mm.
Residual Powder: Proposed Device -
§ 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.
0
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510 (K) SUMMARY
JUN 1 2 2014
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
-
- Submitter's Identification:
Shandong Dawei Medical Products Co., Ltd. No.50. Yongzhou Road Nanshan Industrial Park, Qingzhou, Shandong, 262500 China
- Submitter's Identification:
Date summary prepared: June 4, 2014
-
- Name of the Device:
White Vinyl Exam Gloves Powder Free
- Name of the Device:
-
- Common name/classification name of the Device:
White Vinyl Exam Gloves Powder Free
- Common name/classification name of the Device:
-
- Trade Name
White Vinyl Exam Gloves Powder Free
- Trade Name
5. Contact Person:
Sophie Hao, Tel: 909-548-4828 Email: sophie.hxf1989@gmail.com
6. Predicate Device Information:
Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)
7. Device Description:
Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free
1
Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.
8. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or linger to prevent contamination between patient and examiner.
(). Comparison to Predicate Devices:
Shandong Dawei Medical Products Co., Ltd. White Vinvi Exam Gloves Powder Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. (K992821)
1 (). Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Shandong Dawei Medical Products Co., I.td. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQI. 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5. Inspection Level I, 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.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
-
- Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
- Discussion of Clinical Tests Performed:
l 2. Conclusions:
The conclusion draws from the nonclinical and clinical test that demonstrate that the as safe, as effective, and performs as well as, or better than the legally market predicate device Shijiazhuang Hongxiang Plastic Products Co., Ltd. Powder-free Vinyl Patient Examination Gloves (K992821). Our White Vinvl Exam Gloves Powder Free conform fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims.
2
| Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material, |
|---|
| Physical, Biocompatibility, and Performance Testing |
100 - 100 -
| Proposed Device | Predicate Device (K992821) | |
|---|---|---|
| Shandong Dawei Medical Products Co., | Shiiiazhuang Hongxiang | |
| Description | Ltd. White Vinyl Exam Gloves Powder | Powder-free Vinyl Patient |
| Free | Examination Gloves | |
| A garment covering the hand and wrist | A garment covering the hand | |
| Labeling: Instruction | area. Clovers have separate openings for | and wrist area. Clovers have |
| for use | each finger and the thumb. | separate openings for each |
| finger and the thumb. | ||
| Substantially equivalent | ||
| Labels include: Product name: color; | Labels include: Product name; | |
| Labeling: Labels on | "single use Only" size, piece count, lot | "single use Only" size, piece |
| the carton | distributor | |
| number. | ||
| name. | ||
| and | count, distributor name, and | |
| manufacturer address. | manufacturer address. | |
| Substantially equivalem | ||
| disposable device intended | ||
| র্ব | ||
| for | A disposable device intended | |
| medical purposes that is worn upon the | for medical purposes that is | |
| examiner's hands or lingers to prevent | upon the examiner's | |
| worn | ||
| Indication For Use | contamination between patient | |
| and | hands or fingers to prevent | |
| examiner. | contamination between patient | |
| and examiner. | ||
| Substantially equivalent | ||
| Poly Vinyl Chloride | Poly Vinvl Chloride | |
| Device Materials | Polyurethane | Polyurethane |
| Diisononyl Phthalate (DINP) | Diisononyl Phthalate (DINP) | |
| Average Tensile Strength (Mpa): 16.84 | Tensile | |
| Strength | ||
| Average | ||
| Before Aging: Tensile | Average Ultimate Elongations: 520% | (Mpa): 16.80 |
| Strength(Mpa) and | Average Ultimate Elongations: | |
| Ultimate Elongations | 510% | |
| Substantially equivalent | ||
| Average Tensile Strength (Mpa): 14.96 | Average | |
| Tensile | ||
| Strength | ||
| After Aging: Tensile | Average Ultimate Elongations: 481% | (Mpa): 15 |
| Strength(Mpa) and | Average Ultimate Elongations: | |
| Ultimate Elongations | 480% | |
| Substantially equivalent | ||
| Overall Length on | Average over 232.23mm | Average over 232mm |
| Medium Size | Substantially equivalent | |
| Width of Palm on | Average 95mm | Average 96 mm |
| Medium Size | Substantially equivalent | |
| Average 0.095 mm | Average 0.096 mm | |
| Palm Thickness | Substantially equivalent | |
| Figure Thickness | Average 0.090 mm | Average 0.091 mm |
| Residual Powder | According to ASTM D6124-06 | |
| Standard Test Method for Residual | ||
| Powder on Medical gloves for the | ||
| determination of residual powder | ||
| content. Testing result indicates the | ||
| weight of all types of residual or powder | ||
| on finished powder-free gloves as Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health |
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) ド140322
Device Name
White Vinyl Exam Gloves Powder Free
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or lingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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