(177 days)
Not Found
No
The device is a disposable glove, and the description focuses on material properties, testing standards, and resistance to chemotherapy drugs. There is no mention of AI or ML.
No
The device, an examination glove, is intended to prevent contamination between the patient and examiner, not to treat or alleviate a disease or condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose medical conditions.
No
The device description clearly indicates a physical product (gloves) and mentions testing related to material properties and resistance to chemicals, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- Device Description: The description details the physical characteristics and testing performed on the gloves, focusing on their barrier properties and resistance to chemotherapy drugs.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze human specimens in this manner.
- Regulatory Classification: The predicate device (K092411) is described as "Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera," which falls under the regulatory classification for medical gloves (typically Class I or II, depending on the specific claims and risks). These are not classified as IVDs.
The testing for chemotherapy drug resistance is a performance characteristic of the glove as a barrier, not an indication that it is used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Product: Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
Product: Blue with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA
Device Description
Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs meets all the requirements of ASTM D 6978-05, ASTM D6319-00a(2005) and FDA 21 CFT 880.6250.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Resistance to permeation by Chemotherapy Drugs: ASTM D6978-05. Results: Meets.
Biocompatibility: Primary Skin Irritation in Rabbits. Results: Passes (Not a primary skin irritant).
Biocompatibility: Dermal Sensitization. Results: Passes (Not a primary skin irritant).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
R101436
510(k) SUMMARY
1.0 Submitter
NOV 1 7 2010
Name Street Address Phone No. Fax No.
Shen Wei (USA) Inc. 33278 Central Ave., Suite 102 Union City, CA. 94587 (510)429-8692 (510)487-5347
x No.
(St
Date of Summary Prepared: 08/12/10 Prepared by: Albert Li
2.0 Name of the device:
Glove Proprietary or Trade Name: Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs
Common Name: Exam gloves
Classification Name: Patient examination glove, Specialty Chemotherapy (per 21 CFR 880.6250 product code LZC)
Classification Information: Class I Nitrile patient examination glove 80LZC, powder-free and meeting all the requirements of ASTM D 6319-00a-05 and is tested with chemotherapy drugs according to ASTM D 6978-05.
Identification of the Legally Marketed Device: 3.0 :
Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera Regulatory Class I Nitrile patient examination Product code: 80LZA 510(k): K092411
4.0 Description of the Device:
Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs meets all the requirements of ASTM D 6978-05, ASTM D6319-00a(2005) and FDA 21 CFT 880.6250.
રું... Intended Use of Device:
Product: Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine,
1
KIDI436
Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
| Chemotherapy Drug Permeation (Breakthrough Detection Time) in Min | |
|---|---|
| The following chemicals have been tested with these gloves. | |
| Cyclophosphamide | >240 |
| Doxorubicin HCl (Adriamycin) | >240 |
| *Carmustine | 0.68 |
| Etoposide | >240 |
| Fluorouracil (Adrucil) | >240 |
| Paclitaxel (Taxol) | >240 |
| *ThioTEPA | 34.21 |
| Dacarbazine | >240 |
| Cisplatin | >240 |
Please note that the following drug have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 0.68 minutes.
Please note that the following drug have extremely low permeation times of less than 60 minutes, Thiotepa has an average breakthrough time of 34.21 minutes.
5.1 Intended Use of Device:
Product: Blue with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
| Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. | |||
|---|---|---|---|
| The following chemicals have been tested with these gloves. | |||
| Cyclophosphamide | >240 | ||
| Doxorubicin HCl (Adriamycin) | >240 | ||
| *Carmustine | 2.10 | ||
| Etoposide | >240 | ||
| Fluorouracil (Adrucil) | >240 | ||
| Paclitaxel (Taxol) | >240 | ||
| *ThioTEPA | 27.17 | ||
| Dacarbazine | >240 | ||
| Cisplatin | >240 |
Please note that the following drugs have extremely low permeation times of fess than 30 minutes, Carmustine has an average breakthrough time of 2.10 minutes. Thiotepa has an average breakthrough time of 27.17 minutes.
2
2
Summary of Technological Characteristics for Modified Device: 6.0
Blue and Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe -Vera, Tested-for-use-with-Chemotherapy-Drugs are summarized with.the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a05 | Meets |
| Physical Properties | ASTM D 6319-00a05 | Meets |
| Freedom from pinholes | ASTM D 5151-06 | Meets (AQL 2.5) |
| Powder Residual | ASTM D 6124-06 | Meets (240 |
| *Carmustine | 2.10 | |
| Doxorubicin HCl (Adriamycin) | >240 | |
| Etoposide | >240 | |
| Fluorouracil (Adrucil) | >240 | |
| Paclitaxel (Taxol) | >240 | |
| *ThioTEPA | 27.17 | |
| Dacarbazine | >240 | |
| Cisplatin | >240 |
Please note that the following drugs have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 2.10 minutes. Thiotepa has an average breakthrough time of 27.17 minutes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Elaine S. Manhall
OFF) for SFC
Infection Control, Dent
Prescription Use
FR 001-100
Per 21CFR 801.109
510(k) Number: K
7
1-B. Indiction for Use_
INDICATION FOR USE
NOV 1 / 2010
Applicant: Shen Wei (USA) Inc.
- Device Name: Red with Pearlescent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs
Indication For Use:
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
| Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. | |
|---|---|
| The following chemicals have been tested with these gloves. | |
| Cyclophosphamide | >240 |
| Doxorubicin HCl (Adriamycin) | >240 |
| *Carmustine | 0.68 |
| Etoposide | >240 |
| Fluorouracil (Adrucil) | >240 |
| Paclitaxel (Taxol) | >240 |
| *ThioTEPA | 34.21 |
| Dacarbazine | >240 |
| Cisplatin | >240 |
Please note that the following drug have extremely low permeation times of less than 30 minutes. Carmustine has an average breakthrough time of 0.68 minutes.
Please note that the following drug have extremely low permeation times of less than 60 minutes, Thiotepa has an average breakthrough time of 34.21 minutes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Elaine S. Mayhall
Prescription Use Per 21CFR 801.109
510(k) Number: